Bone graft delivery devices, systems and kits

ABSTRACT

A bone graft delivery kit includes a hollow tube having a proximal end and a distal end. The hollow tube is configured to convey graft material to a graft receiving area in a patient. The hollow tube can be connected to an implant. The kit further includes a plunger to facilitate moving the graft material through the hollow tube.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/424,205, filed Feb. 3, 2017, which claims priority to U.S.Provisional Patent Application Ser. No. 62/290,755, filed Feb. 3, 2016,the entire disclosures of which are hereby incorporated by reference intheir entireties. This application is also a Continuation-in-Part ofU.S. patent application Ser. No. 14/887,598, filed Oct. 20, 2015 andissued as U.S. Pat. No. 9,629,729, which is a Continuation-in-Part ofU.S. patent application Ser. No. 14/263,963, filed Apr. 28, 2014 andissued as U.S. Pat. No. 9,186,193, which is a Continuation-in-Part ofU.S. patent application Ser. No. 14/088,148, filed Nov. 22, 2013 andissued as U.S. Pat. No. 8,709,088, which is a Continuation of U.S.patent application Ser. No. 13/947,255, filed Jul. 22, 2013 and issuedas U.S. Pat. No. 8,685,031, which is a Continuation-in-Part of U.S.patent application Ser. No. 13/714,971, filed Dec. 14, 2012 and issuedas U.S. Pat. No. 9,173,694, which is a Continuation-in-Part of U.S.patent application Ser. No. 13/367,295, filed Feb. 6, 2012 and issued asU.S. Pat. No. 9,060,877, which is a Continuation-in-Part of U.S. patentapplication Ser. No. 12/886,452, filed Sep. 20, 2010 and issued as U.S.Pat. No. 8,906,028, which claims priority from U.S. Provisional PatentApplication Ser. No. 61/243,664, filed Sep. 18, 2009, the entiredisclosures of which are hereby incorporated by reference in theirentireties.

FIELD OF THE INVENTION

The disclosure relates generally to bone graft delivery devices andmethods of use, such as bone graft delivery devices comprisingdetachable handles.

BACKGROUND OF THE INVENTION

Individuals who suffer degenerative disc disease, natural spinedeformations, a herniated disc, spine injuries or other spine disordersmay require surgery on the affected region to relieve the individualfrom pain and prevent further injury to the spine and nerves. Spinalsurgery may involve removal of damaged joint tissue, insertion of atissue implant and/or fixation of two or more adjacent vertebral bodies.In some instances a medical implant is also inserted, such as a fusioncage. The surgical procedure will vary depending on the nature andextent of the injury. Generally, there are five main types of lumbarfusion, including: posterior lumbar fusion (“PLF”), posterior lumbarinterbody fusion (“PLIF”), anterior lumbar interbody fusion (“ALIF”),circumferential 360 fusion, and transforaminal lumbar interbody fusion(“TLIF”). More recently, direct lateral interbody fusion (“D-LIF”) hasbecome available. A posterior approach is one that accesses the surgicalsite from the patient's back, an anterior approach is one that accessesthe surgical site from the patient's front or chest, and a directlateral approach is on that accesses the surgical site from thepatient's side. There are similar approaches for fusion in the interbodyor cervical spine regions. For a general background on some of theseprocedures and the tools and apparatus used in certain procedures, seeU.S. Prov. Pat. Appl. No. 61/120,260 filed on Dec. 5, 2008, the entiredisclosure of which is incorporated by reference in its entirety. Inaddition, further background on procedures and tools and apparatus usedin spinal procedures is found in U.S. patent application Ser. No.12/632,720 filed on Dec. 7, 2009, the entire disclosure of which isincorporated by reference in its entirety.

Vertebrectomy, or the removal or excision of a vertebra, is another typeof spinal surgery that may be necessary to alleviate pain and/or correctspinal defects, such as when disk material above and below a particularvertebra protrudes from the spine and contacts the spinal cord. Once theproblematic vertebra is removed, a specialized fusion cage (also calleda vertebrectomy cage) may be inserted into its place to restorestructural continuity to the spine.

Some disadvantages of traditional methods of spinal surgery include, forexample, the pain associated with the procedure, the length of theprocedure, the complexity of implements used to carry out the procedure,the prolonged hospitalization required to manage pain, the risk ofinfection due to the invasive nature of the procedure, and the possiblerequirement of a second procedure to harvest autograft bone from theiliac crest or other suitable site on the patient for generating therequired quantity of cancellous and/or cortical bone.

A variety of semisolid bone graft materials are available on the marketwhich ostensibly increase spinal fusion rates without the morbidity ofautograft bone harvest. Each of the manufacturers espouses their productas the most advantageous for healing. These products all have similarhandling characteristics and the literature reveals that they havesimilar healing prospects. They come in a syringe and it is up to thesurgeon to apply the selected material to the target site. The mostcommon site for application is to the disk space after it has beenprepared to a bleeding bed and ready to accept a cage and/or thegrafting material. This represents a long and narrow channel even inopen procedures. The surgeon is left to his own devices as to how to getthe graft from its container to the active site. The devices which havebeen used have included a “caulking gun” construct and a variety ofbarrel shaft with a plunger design.

Bone graft typically includes crushed bone (cancellous and cortical), ora combination of these (and/or other natural materials), and may furthercomprise synthetic biocompatible materials. Bone graft of this type isintended to stimulate growth of healthy bone. As used herein, “bonegraft” shall mean materials made up entirely of natural materials,entirely of synthetic biocompatible materials, or any combination ofthese materials. Bone graft often is provided by the supplier in a gelor slurry form, as opposed to a dry or granule form. Many companiesprovide various forms of bone graft in varying degrees of liquidity andviscosity, which may cause problems in certain prior art deliverydevices in both prepackaged or packaged by the surgeon embodiments. Inaddition, the method of delivery of bone graft to a particular locationvaries depending on the form of the bone graft utilized.

Autogenous bone (bone from the patient) or allograft bone (bone fromanother individual) are the most commonly used materials to induce boneformation. Generally, small pieces of bone are placed into the spacebetween the vertebrae to be fused. Sometimes larger solid pieces of boneare used to provide immediate structural support. Autogenous bone isgenerally considered superior at promoting fusion. However, thisprocedure requires extra surgery to remove bone from another area of thepatient's body such as the pelvis or fibula. Thus, it has been reportedthat about 30 percent of patients have significant pain and tendernessat the graft harvest site, which may be prolonged, and in some casesoutlast the back pain the procedure intended to correct. Similarly,allograft bone and other bone graft substitutes, although eliminatingthe need for a second surgery, have drawbacks in that they have yet tobe proven as cost effective and efficacious substitutes for autogenousbone fusion.

An alternative to autogenous or allograft bone is the use of growthfactors that promote bone formation. For example, studies have shownthat the use of bone morphogenic proteins (“BMPs”) results in betteroverall fusion, less time in the operating room and, more importantly,fewer complications for patients because it eliminates the need for thesecond surgery. However, use of BMPs, although efficacious in promotingbone growth, can be prohibitively expensive.

Another alternative is the use of a genetically engineered version of anaturally occurring bone growth factor. This approach also haslimitations. Specifically, surgeons have expressed concerns thatgenetically engineered BMPs can dramatically speed the growth ofcancerous cells or cause non-cancerous cells to become more sinister.Another concern is unwanted bone creation. There is a chance that bonegenerated by genetically engineered BMPs could form over the delicatenerve endings in the spine or, worse, somewhere else in the body.

Many different methods and approaches have been attempted to induce boneformation or to promote spinal fusion. The traditional devices forinserting bone graft impair the surgeon's visualization of the operativesite, which can lead to imprecise insertion of bone graft and possibleharm to the patient. The caulking gun and the collection of largebarrel/plunger designs typically present components at the top of theirstructure which block the view of the surgical site. The surgeon mustthen resort to applying pressure to the surgical site to approximate thelocation of the device's delivery area. Such rough maneuvering canresult in imprecise placement of bone graft, and in some cases, ruptureof the surgical area by penetrating the annulus and entering theabdominal cavity. Also, in some surgical procedures, the devices forinserting bone graft material are applied within a cannula inserted orplaced in the surgical area, further limiting the size and/or profile ofthe bone graft insertion device. When a cannula is involved, sometraditional devices such as the large barrel/plunger designs and/or thechalking gun designs simply cannot be used as they cannot be insertedwithin the cannula.

Traditional devices for inserting bone graft deliver the bone graftmaterial at the bottom of the delivery device along the device'slongitudinal axis. Such a delivery method causes the bone graftingmaterial to become impacted at the bottom of the delivery device, andpromotes risk of rupture of the surgical area by penetrating the annulusand entering the abdominal cavity. Further, traditional devices thatdeliver bone graft material along their longitudinal axis may causerupture of the surgical area or harm to the patient because of theensuing pressure imparted by the ejected bone graft material from thelongitudinal axis of the device.

Traditional devices for inserting a fusion cage or other medicalimplants into a patient's spine or other surgical area are distinct andseparate from traditional devices that deliver bone graft material tothe surgical site. For example, once an implant has been positioned,then bone growth material is packed into the internal cavity of thefusion cage. Also, sometimes the process is reversed, i.e., the bonegrowth is inserted first, and then the implant. These bone growthinducing substances come into immediate contact with the bone from thevertebral bone structures which project into the internal cavity throughthe apertures. Two devices are thus traditionally used to insert bonegraft material into a patient's spine and to position and insert afusion cage. These devices thus necessitate a disc space preparationfollowed by introduction of the biologic materials necessary to inducefusion and, in a separate step, application of a structural interbodyfusion cage.

The problems associated with separate administration of the biologicmaterial bone graft material and the insertion of a fusion cage includeapplying the graft material in the path of the cage, restricting andlimiting the biologic material dispersed within the disk space, andrequiring that the fusion cage be pushed back into the same place thatthe fusion material delivery device was, which can lead to additionaltrauma to the delicate nerve structures.

Fusion cages provide a space for inserting a bone graft between adjacentportions of bone. Such cages are often made of titanium and are hollow,threaded, and porous in order to allow a bone graft contained within theinterior of the cage of grow through the cage into adjacent vertebralbodies. Such cages are used to treat a variety of spinal disorders,including degenerative disc diseases such as Grade I or IIspondylolistheses of the lumbar spine.

Surgically implantable intervertebral fusion cages are well known in theart and have been actively used to perform spinal fusion procedures formany years. Their use became popularized during the mid 1990's with theintroduction of the BAK Device from the Zimmer Inc., a specificintervertebral fusion cage that has been implanted worldwide more thanany other intervertebral fusion cage system. The BAK system is afenestrated, threaded, cylindrical, titanium alloy device that iscapable of being implanted into a patient as described above through ananterior or posterior approach, and is indicated for cervical and lumbarspinal surgery. The BAK system typifies a spinal fusion cage in that itis a highly fenestrated, hollow structure that will fit between twovertebrae at the location of the intervertebral disc.

Spinal fusion cages may be placed in front of the spine, a procedureknown as anterior lumbar interbody fusion, or ALIF, or placed in back ofthe spine. The cages are generally inserted through a traditional openoperation, though laparoscopic or percutaneous insertion techniques mayalso be used. Cages may also be placed through a posterior lumbarinterbody fusion, or PLIF, technique, involving placement of the cagethrough a midline incision in the back, or through a direct lateralinterbody fusion, or D-LIF, technique, involving placement of the cagethrough an incision in the side.

A typical procedure for inserting a common threaded and impacted fusioncage is as follows. First, the disc space between two vertebrae of thelumbar spine is opened using a wedge or other device on a first side ofthe vertebrae. The disk space is then prepared to receive a fusion cage.Conventionally, a threaded cage is inserted into the bore and the wedgeis removed. A disk space at the first side of the vertebrae is thenprepared, and a second threaded fusion cage inserted into the bore.Alternatively, the disk space between adjacent vertebrae may simply becleared and a cage inserted therein. Often, only one cage is insertedobliquely into the disk space. Use of a threaded cage may be foregone infavor of a rectangular or pellet-shaped cage that is simply insertedinto the disk space. Lastly, bone graft material may be inserted intothe surgical area using separate tools and devices.

U.S. Pat. No. 4,743,256 issued to Brantigan (“Brantigan”) discloses atraditional spinal back surgical method involving the implantation of aspinal fusion cage. The cage surfaces are shaped to fit within preparedendplates of the vertebrae to integrate the implant with the vertebraeand to provide a permanent load-bearing strut for maintaining the discspace. Brantigan teaches that these cages typically consist of ahomogeneous nonresorbable material such as carbon-reinforced polymerssuch as polyether ether ketone (PEEK) or polyether ketone ether ketoneketone (“PEKEKK”). Although these cages have demonstrated an ability tofacilitate fusion, a sufficient fusion is sometimes not achieved betweenthe bone chips housed within the cage and the vertebral endplates. Inparticular, achieving a complete fusion in the middle portion of thecage has been particularly problematic. As shown in FIG. 6 herein, theupper U and lower L surfaces of these cages C have large transversepores P which facilitate bone ingrowth, and these pores lead to an innervoid space IVS which houses bone graft (not shown) which facilitates thedesired fusion. In any case, Brantigan teaches the separate process andprocedure for the insertion of a fusion cage and the insertion of bonegraft. Indeed, local bone graft harvested from the channel cuts into thevertebrae to receive the plug supplements the fusion.

U.S. Pat. No. 7,846,210 issued to Perez-Cruet et al. (“Perez-Cruet”)discloses an interbody device assembly consisting of a fusion device andan insertion device. The insertion device positions the fusion devicebetween two vertebrae, provides bone graft material, and then detachesfrom the fusion device, leaving the fusion device in place to restoredisc space height. However, the Perez-Cruet device is designed toreceive bone graft material from its insertion device and distribute thematerial away from the fusion device. In most embodiments of the fusiondevice, a center plate is positioned immediately downstream of thereceived bone graft material and directs the bone graft to opposingsides of the fusion device. (See, for example, FIG. 20 depicting plate308 directing bone graft material 392 along the exterior sides of thefusion device 302). As such, the Perez-Cruet fusion device is unlikelyto completely fill the areas near of its fusion cage and deliver bonegraft material to the surrounding bone graft site. Furthermore, none ofthe Perez-Cruet fusion device embodiments feature a defined interiorspace or a cage-style design. Indeed, the Perez-Cruet fusion deviceexplicitly teaches away from a contained-interior, fusion-cage-styledevice, asserting that its fusion device fills all of the disc space asopposed to a cage design, which contains the bone material. Furthermore,the Perez-Cruet does not feature a distal tip that functions toprecisely position the fusion device and stabilize the device duringdelivery of bone graft material.

Prior art bone graft delivery devices typically must come pre-loadedwith bone graft, or alternatively require constant loading (wherepermissible) in order to constantly have the desired supply of bonegraft available. Moreover, these bone graft delivery devices generallycannot handle particulate bone graft of varying or irregular particulatesize. Furthermore, the prior art devices for inserting a fusion cage orother medical implant into a patient's spine or other surgical area arecommonly distinct and separate from traditional devices that deliverbone graft material to the surgical site. As such, two devices aretraditionally used to insert bone graft material into a patient's spineand to position and insert a fusion cage. The problems associated withseparate administration of the biologic material bone graft material andthe insertion of a fusion cage include applying the graft material inthe path of the cage, restricting and limiting the biologic materialdispersed within the disk space, and requiring that the fusion cage bepushed back into the same place that the fusion material delivery devicewas, which can lead to additional trauma to the delicate nervestructures. These problems can be a great inconvenience, cause avoidabletrauma to a patient and make these prior art devices unsuitable in manyprocedures.

Therefore, there is a long-felt need for an apparatus and method fornear-simultaneous and integrated precision delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants in a patient's spine. The present invention solves these needs.The present invention allows biologic material to flow directly to thefusion cage and be dispersed within the disc space in a single step, andcan precisely and simply deliver particulate bone graft of varying orirregular particulate size. Thus, the present invention allowsapplication of bone graft material through a detachable fusion cage,eliminates otherwise restriction of the volume of biologic material thatmay be dispersed within the disk space, and eliminates the requirementthat the fusion cage be pushed back into the same place that the fusionmaterial delivery device was, which can lead to additional trauma to thedelicate nerve structures.

SUMMARY OF THE INVENTION

A variety of instrumentation techniques have become available to assistwith lumbar interbody stabilization. These include different approachesfor placing fusion cages (oblique, lateral, anterior or posterior),using stackable cages, expandable cages and the application of cagecoatings. Although this is a limited inventory, these availableinventive strategies do not assist the surgeon with the most vexingproblem of interbody fusion: delivery of bone graft or bone graftextenders, (collectively, BG) to the interbody space.

Bone graft (“BG”) material it is a “compressible fluid” and a pressureapplied to it by the plunger of a conventional, end-dispensing bonegraft delivery tool (BGDT) preferentially drives out the liquid part ofthe mixture, leaving a condensed plug of the graft material trappedwithin the cylindrical tool. Removing, clearing and reinserting thecannula can traumatize the neighboring nerve tissue. A fixed funnelprovided on a conventional BGDT prevents a surgeon from visualizing thetip of the cannula as it is placed in the disk space annulotomy. Thisputs the contents of the spinal canal at risk during BGDT insertion.Additionally, a tip of the cannula is round and end-dispensing, andcannot enter a collapsed disc space without damaging the endplates orskating off to an undesired location. Finally, the conventional,end-dispensing delivery device deposits BG directly in the path of thefusion cage to be applied and does not disperse the graft material intothe surrounding, prepared disk space.

Based upon these considerations, novel BGDTs are provided herein thatcomprise a detachable funnel and an increased internal cross sectionalarea to improve the flow of BG material. Devices of the presentdisclosure comprise a modified cannula tip to allow entrance into acollapsed disk space and large portals are provided on the sides of thecannula to allow the BG to exit into the prepared disk space out of theway of the fusion cage.

Certain embodiments of the present disclosure relate to an apparatus andmethod for near-simultaneous and integrated delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants in a patient's spine. The integrated fusion cage and deliverydevice (the “device”) is comprised generally of a tubular member and aplunger for expelling bone graft from the tubular member, through asurgical fusion cage, and into a bone graft receiving area, thendisengaging the fusion cage at the surgical site in a human patient.Thus, the apparatus and method allows the biologic material to flowdirectly into and through the fusion cage and dispersed within the discspace in a single step, and leave the detachable fusion cage in thesurgical area. In one embodiment, the integrated fusion cage is anexpandable integrated fusion cage. Other embodiments and alternatives tothis device are described in greater detail below.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the surgicalprocedures in which bone graft is used and to further describe thevarious tools and other apparatus commonly associated therewith: U.S.Pat. No. 6,309,395 to Smith et al.; U.S. Pat. No. 6,142,998 to Smith etal.; U.S. Pat. No. 7,014,640 to Kemppanien et al.; U.S. Pat. No.7,406,775 to Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson; U.S.Pat. No. 7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson; U.S.Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, et al.;U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to Cornwall,et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat. No. 6,328,738 toSuddaby; U.S. Pat. No. 6,290,724 to Marino; U.S. Pat. No. 6,113,602 toSand; U.S. Pat. No. 6,030,401 to Marino; U.S. Pat. No. 5,865,846 toBryan, et al.; U.S. Pat. No. 5,569,246 to Ojima, et al.; U.S. Pat. No.5,527,312 to Ray; and U.S. Pat. Appl. No. 2008/0255564 to Michelson.

By way of providing additional background, context, and to furthersatisfy the written description requirements of 35 U.S.C. § 112, thefollowing references are incorporated by reference in their entiretiesfor the express purpose of explaining the nature of the surgicalprocedures in which fusion cages are used and to further describe thevarious tools and other apparatus commonly associated therewith: U.S.Pat. No. 6,569,201 to Moumene et al.; U.S. Pat. No. 6,159,211 to Borianiet al.; U.S. Pat. No. 4,743,256 to Brantigan; U.S. Pat. Appl.2007/0043442 to Abernathie et al.; U.S. Pat. Nos. 3,855,638 and4,206,516 to Pilliar; U.S. Pat. No. 5,906,616 issued to Pavlov et al.;U.S. Pat. No. 5,702,449 to McKay; U.S. Pat. No. 6,569,201 to Moumene etal.; PCT Appl. No. WO 99/08627 to Gresser; U.S. Pat. Appl. 2012/0022651to Akyuz et al.; U.S. Pat. Appl. 2011/0015748 to Molz et al.; U.S. Pat.Appl. 2010/0249934 to Melkent; U.S. Pat. Appl. 2009/0187194 to Hamada;U.S. Pat. No. 7,867,277 issued to Tohmeh; U.S. Pat. No. 7,846,210 toPerez-Cruet et al.; U.S. Pat. No. 7,985,256 issued to Grotz et al.; U.S.Pat. Appl. 2010/0198140 to Lawson; and U.S. Pat. Appl. 2010/0262245 toAlfaro et al.

By way of providing additional background and context, the followingreferences are also incorporated by reference in their entireties forthe purpose of explaining the nature of spinal fusion and devices andmethods commonly associated therewith: U.S. Pat. No. 7,595,043 issued toHedrick et al.; U.S. Pat. No. 6,890,728 to Dolecek et al.; U.S. Pat. No.7,364,657 to Mandrusov, and U.S. Pat. No. 8,088,163 to Kleiner.

In addition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith: U.S. Pat. No.D647,202 entitled “Bone Marrow Harvesting Device” to Scifert issued Oct.18, 2011; U.S. Pat. No. 7,897,164 entitled “Compositions and Methods forNucleus Pulposus Regeneration” to Seifert issued Mar. 1, 2011; US Pat.Appl. No. 2010/0112029 entitled “Compositions and Methods for NucleusPulposus Regeneration” to Scifert issued May 6, 2010; US Pat. Appl. No.2010/0021518 entitled “Foam Carrier for Bone Grafting” to Scifert issuedJan. 28, 2010; U.S. Pat. No. 7,824,703 entitled “Medical Implants withReservoir(s), and Materials Preparable From Same” to Scifert, et al.,issued Nov. 2, 2010; US Pat. Appl. No. 2006/0247791 entitled“Multi-Purpose Medical Implant Devices” to McKay, et al., issued Nov. 2,2006; US Pat. Appl. 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No. 2010/0004752 entitled “VertebralBody and Disc Space Replacement Devices” to White, et al., issued Jan.7, 2010; U.S. Pat. No. 7,615,078 entitled “Vertebral Body and Disc SpaceReplacement Devices” to White, et al., issued Nov. 10, 2009; U.S. Pat.No. 6,991,653 entitled “Vertebral Body and Disc Space ReplacementDevices” to White, et al., issued Jan. 31, 2006; US Pat. Appl. No.2010/0331847 entitled “Methods and Apparatus for Performing KneeArthroplasty” to Wilkinson, et al., issued Dec. 30, 2010; US Pat. Appl.No. 2006/0116770 entitled “Vertebral Body and Disc Space ReplacementDevices” to White, et al., issued Jun. 1, 2006; and U.S. Pat. No.8,246,572 entitled “Bone Graft Applicator” to Cantor, et al., issuedAug. 21, 2012.

According to varying embodiments described herein, the present inventionis directed to near-simultaneous and integrated delivery of bone graftmaterial during the placement of surgical cages or other medicalimplants into a patient's spine. The delivery of the bone graft materialmay be to any area of the body, and in particular to the intervertebraljoints of the spine, for achieving bone graft fusion. The device may beused without the optional near-simultaneous and integrated placement ofsurgical cages with the delivery of bone graft material. Also, theinvention may be used in the repair of a bone joint or in connectionwith the implantation of prosthetic devices in the body, including, byway of example but not limitation, the hip, knee and a variety of spinaljoints. Additionally, the present invention may be used in primarysurgery, in which a bone graft is being supplied to promote new bonegrowth or to reconstruct a joint for the first time, as well as inrevision surgery, in which a follow-up procedure is being performed inan area that has previously been subject to one or more surgeries.Further, the invention may be used in any application where material isto be delivered with precision to a confined area where access isrestricted, to include surgical procedures, repair of installed oruninstalled mechanical or electrical devices, and arming or disarming ofexplosive devices.

Although well suited for use in human patients, and although much of thediscussion of the present invention is directed toward use in humans,advantages offered by the present invention may be realized in theveterinary and scientific fields for the benefit and study of all typesof animals and biological systems. Additionally, although the fusioncages of the present invention are particularly well-suited forimplantation into the spinal column between two target vertebrae, andalthough much of the discussion of the present invention is directedtoward their use in spinal applications, advantages offered byembodiments of the present invention may also be realized byimplantation at other locations within a patient where the fusion of twoor more bony structures may be desired. As one of skill in the art willappreciate, the present invention has applications in the general fieldof skeletal repair and treatment, with particular application to thetreatment of spinal injuries and diseases. It should be appreciated,however that the principles of the present invention can also findapplication in other areas, specifically where there is a desire toconstrain added fluid material to particular regions. For example, thepresent invention finds application in methods where the objective is toconfine added material to predetermined areas of interest and toprohibit the undesired translocation of such material until an operationis complete and/or until a predetermined later time.

According to various embodiments of the present disclosure, one aspectof the invention is to provide an integrated fusion cage and graftdelivery device that comprises a tubular member, which is substantiallyhollow or contains at least one inner lumen and that has a generallyrectangular cross-sectional shape. This generally rectangularcross-sectional shape offers a larger amount of surface area throughwhich bone graft material may be inserted and ejected from the hollowtubular member. Furthermore, this generally rectangular shape is morecongruent with the size or shape of the annulotomy of most disc spaces,which frequently are accessed by a bone graft delivery device fordelivery of bone graft. However, as one skilled in the art wouldappreciate, the tool cross-section need not be limited to a generallyrectangular shape. For example, cross-sections of an oval shape or thosewith at least one defined angle to include obtuse, acute, and rightangles can provide a shape in some situations that is more congruentwith the size or shape of the annulotomy of a particular disc space. Asubstantially round shape may also be employed that provides the surgeonwith an indication of directional orientation.

The phrase “removably attached” and/or “detachable” is used herein toindicate an attachment of any sort that is readily releasable.

The phrase “integrated fusion cage”, “spinal fusion implant”,“biological implant” and/or “fusion cage” is used here to indicate abiological implant.

According to various embodiments of the present disclosure, it isanother aspect that the hollow tubular member further comprise at leastone opening on a lateral face or surface of the hollow tubular member,at one distal end, for ejecting bone graft material into a bone graftreceiving area, such as a disc space, such that the bone graft materialis ejected from the hollow tubular member through an additional implant,such as a structural cage implant. In addition, the graft material isdispersed into the area of the debrided disc space surrounding andwithin the cage. Furthermore, the structural cage implant is removablyattached to the hollow tubular member so as to be deposited into thesurgical area. Thus, the device may be used in an integrated andnear-simultaneous method for depositing bone graft material into adebrided disc space through a structural cage implant and leaving thestructural implant.

According to various embodiments of the present disclosure, one aspectof the invention is to provide an integrated fusion cage detachablecomponent of the integrated fusion cage and graft delivery device thatcomprises a biological implant that fits over the distal end of thesubstantial hollow tube, and which has a shape that is substantiallycongruent with the distal end of the hollow tube. However, the shape andconfiguration of the integrated fusion cage need not be limited to agenerally rectangular shape. For example, cross-sections of an ovalshape or those with at least one defined angle to include obtuse, acute,and right angles can provide a shape in some situations that is morecongruent with the size or shape of the annulotomy of a particular discspace. A substantially round shape may also be employed that providesthe surgeon with an indication of directional orientation.

In a preferred embodiment, the fusion cage has a tapered tip, andseveral open channels along the medial surfaces. In a preferredembodiment, the fusion cage and/or the bone graft delivery portion ofthe integrated fusion cage and graft delivery device is of oblong orrectangular, or square shape. The integrated fusion cage and graftdelivery device is designed to avoid blocking or impacting bone graftmaterial into a surgical disc space, thereby limiting the bone graftmaterial that may be delivered, and not allowing available fusion spaceto be fully exploited for fusion.

In a preferred embodiment, the fusion cage has a keel-shaped tip toseparate disk and prevent annular penetration. Also, the fusion cage hasdual portals for bone graft discharge. In one embodiment, the medialopenings are larger than the lateral openings. In another embodiment,the medial openings and the lateral openings are of the same size. Inanother embodiment, the medial and the lateral openings are symmetrical.In another embodiment, the medial openings are smaller than the lateralopenings.

Further, the fusion cage may be designed in variable heights and lengthsso that it fits snugly into the prepared disk space.

In a preferred embodiment that is ideal for anterior lumbar interbodyfusion, the fusion cage has two portals for bone graft dischargepositioned on opposite sides of the fusion cage. In a preferredembodiment that is ideal for direct lateral interbody fusion, the fusioncage has six portals for bone graft discharge, with three portals on oneside of the fusion cage and three portals on an opposite side of thefusion cage. And, in a preferred embodiment that is ideal forpost-vertebrectomy use, two opposing wall portions of the fusion cageare substantially porous to bone graft slurry, while the substantialremainder of the wall of the fusion cage is substantially impervious tobone graft slurry.

In another embodiment of the device, the hollow tube engages with thefusion cage via a break-off collar and the plunger inserts into theinterior of the hollow tube. The break-off collar may be severed by anyof several means, to include application of torsion and/or rotationalforce and/or lateral force to the break-off collar, for example bytwisting on the hollow tube and/or the plunger. The break-off collar maybe formed by any of several means, comprising a thinner and/or reducedcross-sectional, that is thickness, a pre-set fracture-line, one or morenotches, a frangible portion defined by a discrete, extended area thatis weaker in one or more respects as compared to surrounding and/oradjacent material, and any means known to those skilled in the art toachieve reliable break-off. Preferably a clean break is achieved suchthat no surgically significant issues arise so such severance of thecage-portion and the hollow for the portion. In other embodiments, otherways devices and features can be employed to achieve separation of orfirst delivery tube structure and a second structure intended to remainin a patient. For example, electric and/or magnetic disconnectingmechanisms can be used in lieu of a physical breaking/severing of twodiscrete portions that define the above-referenced first and secondstructures. A smooth edge preferably remains after such severance of thecage. Moreover, it will be understood as being within the scope of thepresent invention to use more conventional coupling/decouplingmechanisms to achieve desired separation of the first and secondstructures, e.g. bayonet mounted features, tongue and groove,male/female interlocking structures, clamping devices, nestedarrangements, etc., all of which find support in the various citedreferences incorporated herein by reference. In one example method ofuse, the connected hollow tube and fusion cage is inserted into thesurgical area, bone graft material is inserted into the hollow tube (oralready provided as a pre-packaged material), the plunger is pushed intothe hollow tube, so as to deliver bone graft material to the site, thenthe plunger is reversed or pulled-out so to retreat from the site andmove higher or beyond the break-off collar, and then the break-offcollar is broken so as to disengage the fusion cage from the hollow tubeand therein leave the fusion cage at the surgical site. In anotherembodiment of the device, the hollow tube engages with a connectorconduit which in turn connects with the fusion cage via a break-offcollar. One or more connectors connect the hollow tube with theconnector conduit. The hollow tube fits over the connector conduit. Theone or more connectors fit through the hollow tube and the connectorconduit. Alternately, the hollow tube may fit over the connector conduitvia a press-fit, aka interference fit, without need of one or moreconnectors. In one embodiment, the connectors comprise set screws, pinsand tabs. The connector conduit allows, for example, various fusioncages designs to be fitted to a common hollow tube/plunger combination.This allows, for example, the common hollow tube/plunger combination tobe re-sterilized and thus reused in multiple surgical procedures. In oneembodiment, the hollow tube/plunger combination is re-usable and thefusion cage is disposable.

In one embodiment of the connector conduit, the connector conduit is ofcircular cross-section. In another embodiment, the connector conduit isof conical shape, or any shape that allows a transition in diameterbetween the fusion cage and the follow tube.

In one example method of use, the hollow tube is inserted over theconnection conduit (which is attached to the fusion cage), then insertedinto the surgical area, bone graft material is inserted into the hollowtube (or already provided as a pre-packaged material), the plunger ispushed into the hollow tube (and past the connection conduit), so as todeliver bone graft material to the site, then the plunger is reversed orpulled-out so to retreat from the site and move higher or beyond thebreak-off collar, and then the break-off collar is broken so as todisengage the fusion cage from the hollow tube (which is still connectedto the connection conduit) and therein leave the fusion cage at thesurgical site.

The break-off collar may be severed by any of several means, to includeapplication of torsion and/or rotational force and/or lateral force tobreak-off collar, for example by twisting on the hollow tube and/or theplunger.

In one embodiment of the fusion cage, the fusion cage is of rectangularcross-section, such that one pair of opposite sides, for example aheight first pair of sides, has a dimension of approximately 8-14 mm,and a second pair of opposite sides, for example a length dimension, ofapproximately 22-36 mm. One skilled in the art will appreciate that theexact dimensions of the fusion cage may be adapted to conform toparticulars of the surgical site, for example, the relative sizingbetween the particular vertebrae in which bone graft material and/or afusion cage is to be inserted. In other embodiments of the fusion cage,the fusion cage is of a substantially cylindrical shape. For example, apreferred embodiment of a fusion cage for use in an ALIF procedure formsa substantially cylindrical shape, with a height of approximately 8-14mm and a diameter of less than about 36 millimeters. As another example,a preferred embodiment of a fusion cage for use in conjunction with avertebrectomy has a substantially cylindrical shape with a height equalto or greater than the height of the vertebra (or the collective heightof the vertebrae) it is intended to replace and a diameter of less thanabout 36 millimeters. Preferably, the separation “zone” between the cageand the hollow filling tube is at one end of the cage, preferably theend of the cage (when implanted) closer to the incision site.

A preferred method of using the integrated fusion cage and graftdelivery device comprises precisely inserting the integrated fusion cageand graft delivery device, in one or more of the embodiments containedherein, into the surgical area. The integrated fusion cage and graftdelivery device is then filled with bone graft material in its one ormore substantially hollow tubes, the one or more plungers are insertedinto the one or more hollow tubes, and the one or more plunger arepushed into the one or more hollow tubes, guided precisely as enabled bythe minimal profile of the device, therein controllably depositing thebone graft material into the surgical area through and into the surgicalimplant cage. The surgical implant device may then be selectablydetached from the integrated fusion cage and graft delivery device so asto remain at the surgical site.

Another method of using the integrated fusion cage and graft deliverydevice comprises inserting the integrated fusion cage and graft deliverydevice into a prepared disk space, such that the fusion cage portionfits snugly into the prepared disk space (the fusion cage is designed invariable heights and lengths so as to fit snugly into the prepared diskspace), pushing the plunger through the hollow shaft so as to pushbiological fusion material (e.g. bone graft) through the hollow shaft toflow the biological material through the fusion cage's open lateraland/or medial portals in communication with the hollow tube and plunger,thereby delivering biological material into the prepared disk space,after which the fusion cage is detached from the hollow tube and left inthe disk space. Thus, the fusion cage is left in the disk space with amaximum and/or optimal amount of biological material near-simultaneouslydelivered within the fusion cage and/or surrounding the fusion cage inthe disk space.

Using the integrated fusion cage and graft delivery device as describedovercomes a problem associated with the traditional separate applicationof bone graft material and insertion of a fusion cage. Specifically, inthe traditional method, the volume of disk space which does not containbone graft material is limited, which, for example, limits theeffectiveness of the surgical procedure. For example, using thetraditional two-step procedure, bone graft may be inserted into, forexample, a cylindrically-shaped area of radius r to a height h of 8 mm,and then a cylindrically-shaped fusion cage inserted of height h of 14mm. Thus, the surgical area is left without a complete volume of bonegraft material, i.e. because the volume of a cylinder is Volume=πr²h,the bone graft area is left without πr² (14 mm-8 mm), or 6πr² of bonegraft material. (Note that this represents a 75% increase in bone graftmaterial delivered to the surgical site for these example dimensions).This effectively dilutes the bone graft material and reduces itseffectiveness. The present invention can substantially or completelyfill the available disk space with bone graft material, becausedistraction of the disk space is performed substantially simultaneouslywith application of the fusion cage. Because more biological material isdelivered to the prepared disk space, the fusion rate should increase.Also, by directly implanting fusion material, e.g. bone graft material,though a fusion cage positioned for detachment (and then detached) as asingle step, time is saved and there is less manipulation of thesensitive nerve tissue at the fusion site (which increases safety).

Furthermore, the integrated fusion cage and graft delivery device may beused without the surgical implant delivery device portion such that themethod comprises precisely inserting the integrated fusion cage andgraft delivery device, in one or more of the embodiments containedherein, into the surgical area that may already contain one or moreadditional implants, such as a structural cage implant. The integratedfusion cage and graft delivery device is then filled with bone graftmaterial in its one or more substantially hollow tubes, the one or moreplungers are inserted into the one or more hollow tubes, and the one ormore plunger are pushed into the one or more hollow tubes, guidedprecisely as enabled by the minimal profile of the device, thereincontrollably depositing the bone graft material into the surgical areawithout depositing bone graft material into the path of any structuralcage implant or other implant that may already be present.

According to a still further aspect of the present invention, theintegrated fusion cage may be introduced into a spinal target sitewithout the use of the graft delivery device that is through use of anyof a variety of suitable surgical instruments having the capability toengage the implant. The integrated fusion cage is capable of being usedin minimally invasive surgical procedures, needing only a relativelysmall operative corridor for insertion. The integrated fusion cage mayalso be used in open procedures. According to a still further aspect ofthe present invention, the integrated fusion cage of the presentinvention may be used in a variety of configurations in a fusionprocedure, including but not limited to (and by way of example only)unilateral, paired unilateral and bilateral.

Furthermore, the integrated fusion cage and graft delivery device andmethod of use is applicable to position and deliver fusion cages fromthe side, directly anterior or in the anterior fusion cages of thecervical spine.

In a preferred embodiment, the integrated fusion cage and graft deliverydevice comprises a hollow tube or contains at least one inner lumenconstructed to receive bone graft, and a plunger adapted for insertionat least partially within the hollow tube and preferably through thefull extent of the hollow tube. The plunger of some embodiments isgenerally of the same geometric configuration as the hollow interiorpotion of the hollow tube so that the plunger, once fully inserted in tothe hollow tube, is substantially congruent with the hollow interiorportion of the hollow tube, e.g. both the plunger and the hollow tubeare substantially the same shape and/or class. The plunger preferablyextends about the same length as the hollow tube, and further comprisesan end portion, e.g. at least one knob or handle for grasping andmanipulation by a user, or in robotic or automated or semi-automatedcontrol or surgeries, by a machine.

Also according to a preferred embodiment, the hollow interior portion ofthe hollow tube further comprises a sloped or curved surface at a secondend (e.g. positioned near a place for deposit of bone graft material)adjacent and opposite a lateral window or opening in a lateral face ofthe hollow tube. As the interior of the hollow tube comprises a slopedor curved surface at its second end, the plunger also comprises a slopedor curved surface at a second end of the plunger. The plunger terminatesopposite the curved surface at its second end with a laterally facedsurface, which corresponds to the lateral window or opening at thesecond end of the hollow tube. The distal end of the hollow tube isfitted with a substantially conformal fusion cage that covers theexterior surface of the hollow tube, fitted with one or more openingsthat align with one or more openings of the hollow tube. Thus, incooperation, the plunger may be inserted into the opening of the hollowtube, and extended the entire length of the hollow tube, at least to apoint where the laterally faced surface of plunger is in communicationwith the lateral window or opening at the second end of the hollow tube.This configuration permits a user to eject substantially all of the bonegraft material that is placed into the hollow tube in a lateraldirection at the bone graft receiving area, through the substantiallyconformal and detachable fusion cage that covers the exterior surface ofthe hollow tube, optionally detach the detachable fusion cage, during asurgical procedure.

In a preferred embodiment, the integrated fusion cage and graft deliverydevice comprises an integrated fusion cage that comprises a firstproximal end and a second distal end, wherein the first proximal endcontains an opening adapted to allow fitting and/or engagement to thedistal end of the hollow tube. This fitting and/or engagement may beover the external surface of the hollow tube or inside the interior ofthe hollow tube. Further, the integrated fusion cage may comprise one ormore medial openings and one or more lateral openings that align withone or more openings at the distal end of the hollow tube. Further, theintegrated fusion cage may contain surfaces, such as belts orstriations, along one or more medial surfaces of the integrated fusioncage. The integrated fusion cage is configured such that when a plunger,once fully inserted in to the hollow tube, is substantially congruentwith the hollow interior portion of the hollow tube, e.g. both theplunger and the hollow tube are substantially the same shape and/orclass and bone graft material is delivered through the integrated fusioncage into the surgical area.

In one embodiment, a substantially hollow implant is detachablyinterconnected to a distal end of the hollow tube, the implant having aproximal end and a tapered distal end, the tapered distal end having anexterior tapered surface and a tapered interior surface, and the plungeradapted for inserting into the proximal end of the hollow tube, theplunger having a tapered distal end being contoured to the taperedinterior surface of the distal end of the implant to form a conformingfit between the tapered distal end of the plunger and the taperedinterior surface of the distal end of the implant when the plunger isfully inserted into the implant such that bone graft material within thehollow tube is delivered to a graft receiving area through at least oneopening of the implant. Further, the distal end of the implant maycomprise a closed distal tip, and the tapered distal end of the plungermay be wedge-shaped and the tapered interior surface of the closeddistal tip of the distal end of the implant may be wedge-shaped.

The spinal fusion implant of the present invention may be used toprovide temporary or permanent fixation along an orthopedic target site.

The spinal fusion implant of the present invention may be provided withany number of additional features for promoting fusion, such as one ormore apertures extending between the top and bottom surfaces which allowa bony bridge to form through the spinal fusion implant.

The spinal fusion implant may also be provided with any number ofsuitable anti-migration features to prevent the implant from migratingor moving from the disc space after implantation. Suitableanti-migration features may include, but are not necessarily limited to,angled teeth or ridges formed along the top and bottom surfaces of theimplant and/or rod elements disposed within the distal and/or proximalends.

According to a further aspect of the present invention, the spinalfusion implant may be provided with one or more radiographic markers atthe proximal and/or distal ends. These markers allow for a more detailedvisualization of the implant after insertion (through radiography) andallow for a more accurate and effective placement of the implant.

According to a still further aspect of the present invention, the distalend of the spinal fusion implant may have a conical (bullet-shaped)shape including a pair of first tapered (angled) surfaces and a pair ofsecond tapered (angled) surfaces. The first tapered surfaces extendbetween the lateral surfaces and the distal end of the implant, andfunction to distract the vertebrae adjacent to the target intervertebralspace during insertion of the spinal fusion implant. The second taperedsurfaces extend between the top and bottom surfaces and the distal endof the spinal fusion implant, and function to maximize contact with theanterior portion of the cortical ring of each adjacent vertebral body.Furthermore, the second tapered surfaces provide for a better fit withthe contour of the vertebral body endplates, allowing for a moreanterior positioning of the spinal fusion implant and thus advantageousutilization of the cortical rings of the vertebral bodies.

Another embodiment for the integrated fusion cage and graft deliverydevice comprises a detachable fusion cage that is detachable, orremovably attached, by any of several means. As disclosed above, in oneembodiment, the fusion cage is substantially conformal with the distalend of the hollow tube in that it covers the exterior surface of thehollow tube, wherein the fusion cage is configured with one or moreopenings that align with one or more openings of the hollow tube. In onepreferred embodiment, the fusion cage of the integrated fusion cage andgraft delivery device forms an interference fit with the fusion cage,such that when the integrated fusion cage and graft delivery device isinserted into the surgical area, the integrated fusion cage and graftdelivery device presses against bone and/or vertebrates such that whenan axial force is applied to the integrated fusion cage and graftdelivery device in a rearward direction (toward the proximal end of theintegrated fusion cage and graft delivery device), the fusion cagedetaches from the integrated fusion cage and graft delivery device andthereby remains in the surgical area.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, the fusion cage is substantially filledwith bone graft material after the fusion cage is implanted. In anotherembodiment for the integrated fusion cage and graft delivery device andits method of use, the fusion cage is substantially filled with bonegraft material simultaneously with the implantation of the fusion cage.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, the fusion cage and/or the bone graftmaterial associated with the fusion cage may be accessed duringsubsequent surgical operations.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, the fusion cage is a separate device, forexample a pre-packaged implant device, which may be installedindependently from the integrated fusion cage and graft delivery deviceor installed in coordination with the integrated fusion cage and graftdelivery device. In either situation, the device may be used to providebone graft material in and/or around the pre-packaged implant.

In another embodiment for the integrated fusion cage and graft deliverydevice and its method of use, some or all of the bone graft material isprovided as a component of a per-packaged implant. In another embodimentfor the integrated fusion cage and graft delivery device, the detachablefusion cage is detachable by way of a indent-tab that penetrates theinterior of the hollow tube, such, when the plunger is substantiallyinserted into the hollow tube, the indent-tab is pushed out from theinterior of the hollow tube so as to no longer be attached to theintegrated fusion cage and graft delivery device, thereby remaining inthe surgical area.

In another embodiment, the hollow tube is of cylindrical shape andincludes one or more locking tabs or indent tabs configured to engageone or more locking slots of the fusion cage. The locking tabs maypermanently or not permanently engage the locking slots, and may be of ashape to include rectangular, circular and oblong. In one embodiment ofthe locking tabs and locking slots, the locking tabs and locking slotsengage one another by rotating the hollow tube clockwise and arereleased by counterclockwise rotation. In another embodiment of theconfiguration of the locking tabs and locking slots, the locking tabsand locking slots engage one another by rotating the hollow tubecounterclockwise and are released by clockwise rotation.

In another embodiment, the fusion cage has internal ramps which assistin directing the bone graft material to one or more openings in thefusion cage.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of receipt of anelectrical, mechanical, pneumatic, hydraulic or other communicationimparted by the user upon the plunger and/or hollow tube so as to detachthe fusion cage and thereby deposit the fusion cage into the surgicalarea.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a Luer taperor Luer fitting connection, such as in a Luer-Lok® or Luer-Slip®configuration or any other Luer taper or Luer fitting connectionconfiguration. For purposes of illustration, and without wishing to beheld to any one embodiment, the following U.S. Patent Application isincorporated herein by reference in order to provide an illustrative andenabling disclosure and general description of means to selectablydetach the fusion cage of the integrated fusion cage and graft deliverydevice: U.S. Patent Appl. No. 2009/0124980 to Chen.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by way of a pedicledart by threadable rotation to achieve attachment, detachment, and axialmovement. Other ways include a quick key insertion, an external snapdetent, or magnetic attraction or any other structure. For purposes ofillustration, and without wishing to be held to any one embodiment, thefollowing U.S. Patent Application is incorporated herein by reference inorder to provide an illustrative and enabling disclosure and generaldescription of means to selectably detach the fusion cage of theintegrated fusion cage and graft delivery device: U.S. Patent Appl. No.2009/0187194 to Hamada.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of magnetism.More specifically, the detachable fusion cage can be made to feature amagnetic field pattern and a resulting force R that are adjustable andmay be of different character than the rest of the integrated fusioncage and graft delivery device.

With permanent magnets, such adjustments can be made mechanically byorienting various permanent magnet polar geometries and correspondingshapes relative to one another. U.S. Pat. No. 5,595,563 to Moisdondescribes further background regarding such adjustment techniques, whichis hereby incorporated by reference in its entirety. Alternatively oradditionally, electromagnets could be used in combination with permanentmagnets to provide adjustability. In further embodiments, the magnetsand corresponding fields and the resultant magnetic field pattern caninclude both attraction forces from placement of opposite pole types inproximity to one another and repulsion forces from placement of likepole types in proximity to one another. As used herein, “repulsivemagnetic force” or “repulsive force” refers to a force resulting fromthe placement of like magnetic poles in proximity to one another eitherwith or without attractive forces also being present due to oppositemagnetic poles being placed in proximity to one another, and furtherrefers to any one of such forces when multiple instances are present.U.S. Pat. No. 6,387,096 is cited as a source of additional informationconcerning repulsive forces that are provided together with attractivemagnetic forces, which is hereby incorporated by reference. In anotheralternative embodiment example, one or more of surfaces of the fusioncage are roughened or otherwise include bone-engaging structures tosecure purchase with vertebral surfaces. In yet other embodiments, theselectable detachable feature between the detachable fusion cage and theintegrated fusion cage and graft delivery device can include one or moretethers, cables, braids, wires, cords, bands, filaments, fibers, and/orsheets; a nonfabric tube comprised of an organic polymer, metal, and/orcomposite; an accordion or bellows tube type that may or may not includea fabric, filamentous, fibrous, and/or woven structure; a combination ofthese, or such different arrangement as would occur to one skilled inthe art. Alternatively or additionally, the selectable detachablefeature between the detachable fusion cage and the integrated fusioncage and graft delivery device can be arranged to present one or moreopenings between members or portions, where such openings extend betweenend portions of the fusion cage. For purposes of illustration, andwithout wishing to be held to any one embodiment, the following U.S.Patent Application is incorporated herein by reference in order toprovide an illustrative and enabling disclosure and general descriptionof means to selectably detach the fusion cage of the integrated fusioncage and graft delivery device: U.S. Patent Appl. No. 2011/0015748 toMolz et al.

In another embodiment for the integrated fusion cage and graft deliverydevice, the detachable fusion cage is detachable by use of plasmatreatment. The term “plasma” in this context is an ionized gascontaining excited species such as ions, radicals, electrons andphotons. (Lunk and Schmid, Contrib. Plasma Phys., 28: 275 (1998)). Theterm “plasma treatment” refers to a protocol in which a surface ismodified using a plasma generated from process gases including, but notlimited to, O₂, He, N₂, Ar and N₂O. To excite the plasma, energy isapplied to the system through electrodes. This power may be alternatingcurrent (AC), direct current (DC), radiofrequency (RF), or microwavefrequency (MW). The plasma may be generated in a vacuum or atatmospheric pressure. The plasma can also be used to deposit polymeric,ceramic or metallic thin films onto surfaces (Ratner, Ultrathin Films(by Plasma deposition), 11 Polymeric Materials Encyclopedia 8444-8451,(1996)). Plasma treatment is an effective method to uniformly alter thesurface properties of substrates having different or unique size, shapeand geometry including but not limited to bone and bone compositematerials. Plasma Treatment may be employed to effect magneticproperties on elements of the integrated fusion cage and graft deliverydevice, or to provide selectable detachment of the fusion cage. Forpurposes of illustration, and without wishing to be held to any oneembodiment, the following U.S. Patent Application is incorporated hereinby reference in order to provide an illustrative and enabling disclosureand general description of means to selectably detach the fusion cage ofthe integrated fusion cage and graft delivery device: U.S. Pat. No.7,749,555 to Zanella et al.

One having skill in the art will appreciate that the fusion cage may beselectably detachable to the integrated fusion cage and graft deliverydevice, for example, by means that mechanically grasp the head, meansthat attach by vacuum, and means that attach by friction, or other meansknown to those of skill in the art for attaching the head of anapparatus to the shaft of an apparatus.

It is another aspect of the present disclosure that the distal end ofthe integrated fusion cage and graft delivery device be equipped withvarious other tools to aid in the procedure. Such tools may include, forexample, devices used to assess the condition of the implantation siteand surrounding tissue. This may include, for example, a device thattransmits or provides an image or signal which carries an image forvisual inspection and photography. Such an image capture device mayinclude, for example, a device to illuminate the implant site coupledwith an image capture and/or transmission device. Another tool may alsoinclude, for example, a device that aids in irrigation or drainage ofthe surgical site, a tool used to sample or biopsy tissue.

Another embodiment for the integrated fusion cage and graft deliverydevice comprises a hollow tube constructed to receive bone graft, wherethe hollow tube has a proximal and distal end, a plunger adapted forinsertion at least partially within the hollow tube at the proximal endof the hollow tube, whereby the plunger is constructed and arranged withrespect to the hollow tube so as to prevent rotation of the plungerduring insertion into said hollow tube, whereby the plunger has a distalend that is contoured to an interior surface of the distal end of thehollow tube such that the contoured distal end of the plunger is nearlycongruent with the interior surface of the distal end of the hollow tubefor removing substantially all of the bone graft received by the hollowtube and whereby the bone graft is delivered to the graft receivingarea. Still another embodiment provides a rifling structure in thehollow tube interior that facilitates rotational movement of the plunderalong a lengthwise axis of the hollow tube, therein delivering asubstantially steady pressure and/or rate of delivery of the bone graftmaterial as the plunger descends the hollow tube when the plunger isforced through the hollow tube. The rifling or screw-like movement mayalso translate to a predetermined delivery of material per fullrotation, e.g. each 360 degree rotation of the plunger equates to 5 ccof bone graft material delivered to the bone graft site.

Another aspect of the present invention includes providing a hollow tubeand plunger assembly, in which the hollow tube and/or the plungerassembly are disposable. The tube may also be at least portions ofbiocompatible material which can stay in the canal without impairing thefinal implantation. Alternatively, it may thus be a material that isresorbable, such as a resorbable polymer, in the canal afterimplantation, so as not to interfere with the growth of the bone orstability of the implant.

A further embodiment of the invention provides pre-packaged inserts forloading into the hollow tube element, or if there are a plurality ofhollow tube elements, into one or more of the hollow tube elements. Thepre-packaged inserts may be of varying lengths, and/or layered ofdiffering materials or components, to include the patient's own bonegraft matter.

Another embodiment of the present invention provides an integratedfusion cage and graft delivery system, by which a hollow tube and/or ahollow tube/plunger assembly can be prepared prior to opening a patient,thus minimizing the overall impact of the grafting aspect of a surgicalimplantation or other procedure. Moreover, the hollow tube may be madeto be stored with bone graft in it for a period of time, whether thetube is made of plastic, metal or any other material. Depending upon thesurgical application, it may be desirable to only partially fill thetube for storage, so that a plunger can be at least partially insertedat the time of a surgery.

A further embodiment of the present invention provides a bone graftinsertion apparatus comprising a hollow tube constructed to receive bonegraft, the hollow tube having a proximal and distal end whereby thehollow tube contains least one opening on a surface of the distal end ofthe hollow tube. The at least one opening is preferably positioned otherthan completely along the axial or longitudinal axis of the device. Thenumber and size and shape of such openings can vary but are preferablyadapted to deliver bone graft material in a direction substantiallytransverse to the axial extent of the substantially hollow tube. In oneembodiment, two or more apertures are provided. In certain embodiments,apertures are on the same side of the hollow tube, where in others,apertures are on different sides (e.g. opposing sides) of a hollow tube.A plunger, adapted for insertion at least partially within the hollowtube, is constructed and arranged with respect to the hollow tube so asto present at least one substantially flat contour, whereby the plungerhas a distal end that is contoured to an interior surface of the distalend of the hollow tube such that the contoured distal end of the plungeris nearly congruent with the interior surface of the distal end of thehollow tube. This facilitates removing substantially all of the bonegraft received by the hollow tube whereby the bone graft is delivered tothe graft receiving area. It is important to remove substantially all ofthe bone graft material as it is expensive and/or difficult to obtain.

In another embodiment of the present disclosure the distal end of theplunger is flexible to allow, for example, the user to maneuver thedistal end and thereby any bone graft material in the hollow tube to theimplantation site. One skilled in the art will appreciate that theflexible aspect of certain embodiments can be both passive and active innature. Active flexibility and manipulation in the distal end of theplunger may incorporate, for example, the manipulative capabilities ofan endoscope, including components for manipulation such as guidewiresalong the longitudinal axis of the shaft of the plunger.

In another embodiment of the invention, the distal end and the proximalend of the hollow tube are in communication via a conduit to enableelectrical, hydraulic, pneumatic, or mechanical transmission, the latersuch as a wire. Such hydraulic communication allows, for example, amedical or other liquid to be delivered or extracted from the surgicalarea. Such mechanical communication allows, for example, the distal endto be maneuvered precisely.

In another embodiment of the present disclosure, the hollow tube and/orplunger may be curved and/or may have an angular aspect, in addition tothe sloped or curved surface at a second end of the hollow tube/plunger.This shape may, for example, aid the surgeon in more comfortablyintroducing the delivery device to the implant site, be shaped to betteraccommodate implantation sites on right or left sides of the body, or beshaped to better accommodate right or left-handed surgeons. One havingskill in the art will appreciate that the delivery device may havemultiple angles and curved aspects which enable aspects of embodimentsof the present disclosure or aid in ergonomics.

In one embodiment of the present disclosure, the device furthercomprises a footing or shelf at the distal end of the tubular devicethat is nearest the operating site for preventing or mitigating risk ofinjury to the patient during surgery. According to this embodiment, thefooting may be flexible, semi-flexible, semi-rigid or rigid. The footingserves to protect the anatomy of the patient from being penetrated bythe hollow tube of the integrated fusion cage and graft delivery devicewhen the plunger is being inserted or during tamping of the hollow tubeor the plunger by the surgeon, which may occur during the surgicalprocedure for a variety of reasons. In certain embodiments, the distaltip region of the hollow tube comprises a softer, maliable and/or lessrigid material than the remainder of the hollow tube. For example, thedistal tip could be made of a bioactive collagen.

It is yet another aspect of the present disclosure to provide anintegrated fusion cage and graft delivery device that contains one ormore detachable elements for use in an operation where bone graftmaterial must be inserted into the integrated fusion cage and graftdelivery device and ejected to a bone graft receiving area. According tovarious embodiments, these detachable devices may include a detachablefunnel for gathering and inserting bone graft material at a graspableend of the integrated fusion cage and graft delivery device. The presentdisclosure may also comprise a plunger that has a detachable handle,which may be selectively removed to avoid blocking the surgeon's view ofthe operating site. The integrated fusion cage and graft delivery devicemay further comprise a detachable footing or shelf at one distal end ofthe hollow tubular member. In one embodiment this footing or shelf isselectively positionable about various points along the hollow tube. Forexample, a distal portion of the hollow tube has a rotatable portionthat can be positioned to deliver bone graft material to areas of a discspace in a manner such that a surgeon has angular directional control asto where bone graft material is directed. Other detachable elements arealso contemplated with the present invention, such as a funnel at theproximal end of the hollow tube, or exterior or interior guide wiresattached to the hollow tube, or a camera which is positioned near thedelivery site of the bone graft material.

In another embodiment of the invention, the device is configured suchthat the upper or first end of the device (that is, the end in which theplunger is inserted) is not substantially in-line with the second end ofthe device (that is, the end from which bone graft material is emittedand/or a fusion cage is attached). For example, the body of the hollowtube may be configured with an angle or kink along its length, appearingto be rotated along its length. In this embodiment, the plunger elementis flexible and/or conformable so as to flex inside of the tube portionand otherwise traverse through the tube portion. This embodiment of thedevice is useful, for example, when the user requires entry to the discspace at other than a right angle. Further, the angle or kink along thelength of the device may be configured is capable of selectively locking(e.g., by a pin) the upper device portion into a particular position,e.g. so that a desired angle is created between the upper device portionand the remaining portion of the device. The means for communicationitself can be locked to alternatively achieve this objective. In oneembodiment, when the rotating member is in an unlocked mode, the memberis free to rotate in at least one plane. The selective locking mechanismcan be remotely accessed by a user of the tool at the upper end of thehandle by, for example, an external shaft that communicates with thelocking mechanism of the rotating member on the distal end of the body.Yet another aspect of the present disclosure is that the device can bevariably angled to allow for a variety of insertion angles. A ratchetingadapter can be fitted to allow for this application.

The present invention can be used in veterinary conditions, in thethoracic spine or can be used for insertion of a laterally based diskreplacement.

Thus, according to various embodiments of the present disclosure, amethod of introducing bone graft material to a desired operating site(“bone graft receiving area”) is provided by use of a hollow tubularmember comprising a generally rectangular cross-sectional area, wherebythe desired operating area is capable of receiving at least one plunger.The one or more plunger having at least one distal end which is designedto accommodate ejecting bone graft or other material to be inserted intothe joint space or between intervertebral members in a generally lateraldirection, as opposed to a generally longitudinal direction (in relationto the direction of the primary axis of the device).

One skilled in the art will appreciate that the distal end of thetubular device need not be limited to those specific embodimentsdescribed above. Other forms, shapes or designs that enable theforegoing aspects of the present invention are hereby incorporated intothis disclosure. Forms, shapes and designs that relate to the provisionof an end of a tubular device to perform lateral introduction of bone orbone substitute to an operating site are considered to be within thescope of the present disclosure.

One aspect of the present invention provides an integrated fusion cageand graft delivery device system for delivering bone graft, in apartially formed, fully formed or unformed condition to a bone graftreceiving area in a body.

In yet another embodiment the hollow tube of the integrated fusion cageand graft delivery device may further comprise a funnel on the graspableend of the hollow tube, which may be selectively positioned about thegraspable end of the hollow tube, for facilitating insertion of new oradditional bone graft into the hollow tube. The funnel may take on avariety of shapes and sizes, depending on the nature of the bone graftmaterial being inserted in the hollow tube.

One embodiment of the substantially hollow tube provides that the hollowtube is telescoping, thereby allowing its length to be adapted to theparticular desires of the surgeon and/or the surgical area. In thisembodiment, the plunger may also be telescoping to substantially conformto the configuration and/or size and/or shape of the substantiallyhollow tube.

In another embodiment, the size and/or shape of the one or more hollowtubes of the device are sized to fit, and/or not substantially obscureaccess to the aperture of, the cannula or cannulas that the device isfitted through for delivery of bone graft material to the operatingsite. In this embodiment, the device's one or more pair of hollow tubesand plungers do not substantially impair access to the operating sitenor the surgeon's view of the operating site.

In one embodiment of the invention, a bone graft insertion apparatuscomprises: a hollow tube constructed to receive bone graft, said hollowtube having an extended axis and a proximal end and a distal end, saiddistal end having an interior surface; a plunger adapted for insertinginto said proximal end of said hollow tube, said plunger having a distalend being contoured to said interior surface of said distal end of saidhollow tube such that bone graft material within said hollow tube isdelivered to a graft receiving area through at least one opening nearthe distal end of said hollow tube; wherein said graft receiving area isconfigured to accommodate at least one substantially hollow implant.

In another embodiment of the invention, a bone graft insertion apparatuscomprises: a hollow tube constructed to receive bone graft, said hollowtube having a proximal and distal end; whereby said hollow tube containsleast one opening on a surface of said distal end of said hollow tube;whereby said opening on a surface of said distal end of said hollow tubeis positioned other than completely along the axial or longitudinal axisof the device; a plunger adapted for insertion at least partially withinsaid hollow tube at proximal end of said hollow tube; whereby saidplunger is constructed and arranged with respect to said hollow tube soas to present at least one substantially flat contour; whereby saidplunger has a distal end that is contoured to an interior surface ofsaid distal end of said hollow tube such that said contoured distal endof said plunger is nearly congruent with said interior surface of saiddistal end of said hollow tube for removing substantially all of saidbone graft received by said hollow tube; whereby said bone graft isdelivered to a graft receiving area.

In another embodiment of the invention, a method of inserting bone graftcomprises: preparing a surgical area to receive bone graft; inserting atool into said surgical area, said tool consisting essentially of ahollow tube adapted to receive bone graft, a plunger adapted forinsertion into said hollow tube, said plunger constructed to preventrotation during insertion into said hollow tube, said plunger having adistal end contoured to the interior surface of the distal end of saidhollow tube; providing bone graft material into the said hollow tube ofsaid tool; inserting said plunger into the proximal end of said hollowtube; inserting said distal end of said hollow tube of said tool intosurgical area; applying force to said plunger thereby advancing saidplunger through said hollow tube wherein said bone graft is insertedinto said surgical area.

In another embodiment of the invention, an integrated fusion cage andgraft delivery device apparatus comprises: a hollow tube constructed toreceive bone graft, the hollow tube having an extended axis and aproximal end and a distal end, the distal end having an interiorsurface; a plunger adapted for inserting into the proximal end of thehollow tube, the plunger having a distal end being contoured to theinterior surface of the distal end of the hollow tube; a selectablydetachable fusion cage, the selectably detachable fusion cage having atleast one opening that substantially aligns with at least one openingnear the distal end of the hollow tube, such that bone graft materialwithin the hollow tube is delivered to a graft receiving area through atleast one opening of the selectably detachable fusion cage; and theselectably detachable fusion cage having a means for detachment wherebythe fusion cage is delivered to the graft receiving area.

In one embodiment, the device is not a caulking gun style device, thatis the bone graft material and/or the fusion cage are not deliveredand/or positioned using a hand-pump and/or hand-squeeze mechanism.Instead, the device delivers graft material and/or a fusion cage using ahollow tube and plunger arrangement which is not a caulking gun styledevice and further, does not appreciably disrupt or block the user'sview of the surgical site and/or enable precision delivery of bone graftmaterial and/or a fusion cage to the surgical site. Indeed, the deviceis distinctly unlike the chalking gun device of U.S. Pat. Appl. No.2004/0215201 to Lieberman (“Lieberman”), which requires an L-shaped basemember handle, rack teeth to advance a plunger member, and user actionon a lever of the L-shaped base member handle to deploy bone graftmaterial. In one embodiment, the device of this application is not acaulking gun style device and does not comprise rack teeth, a basemember handle and at least one component that obscures user viewing ofthe surgical site. Lieberman is incorporated by reference in itsentirety for all purposes.

Similarly, in one embodiment, the device is distinctly unlike thechalking gun device of U.S. Pat. Appl. No. 2002/0049448 to Sand et al(“Sand”), which requires a gun and trigger mechanism in which the usersqueezes together a gun-style handle to deploy material into bone. TheSand device obstructs the view of the user of the delivery site. In oneembodiment, the device of this application is not a caulking gun styledevice and does not comprise an opposing-levered, gun-style deliverymechanism and at least one component that obscures user viewing of thesurgical site. Sand is incorporated by reference in its entirety for allpurposes.

In one embodiment of the invention, the device is configured to deliverbone graft material substantially laterally from its delivery end, thatis substantially not in the axial direction but rather substantiallyfrom the side and/or in a radial direction. This is distinctly differentthan devices that deliver bone graft material along their vertical axis,that is, along or out their bottom end, and/or obstruct the user view ofthe bone graft and/or fusion cage delivery site, such as that of U.S.Pat. Appl. No. 2010/0087828 to Krueger et al (“Krueger”), U.S. Pat.Appl. No. 2009/0264892 to Beyar et al (“Beyar”), U.S. Pat. Appl. No.2007/0185496 to Beckman et al (“Beckman”), U.S. Pat. Appl. No.2009/0275995 to Truckai et al (“Truckai”) and U.S. Pat. Appl. No.2006/0264964 to Seifert et al (“Seifert”). Krueger, Beyar, Beckman,Truckai and Scifert are incorporated by reference in their entiretiesfor all purposes.

In one embodiment, the device is configured to deliver bone graftmaterial so as to completely fill the defined interior of its fusioncage and subsequently deliver bone graft material to the surroundingbone graft site, rather than, for example, to contain the bone materialas are the fusion cage designs of U.S. Pat. No. 7,846,210 to Perez-Cruet(“Perez-Cruet”). Further, the fusion device of this application featuresa distal tip that functions to precisely position the fusion device andstabilize the device during delivery of bone graft material. Perez-Cruetis incorporated by reference in its entirety for all purposes.

In one embodiment, a bone graft insertion apparatus is disclosed, thebone graft insertion apparatus comprising: a hollow tube constructed toreceive bone graft, said hollow tube having an extended axis and aproximal end and a distal end, said distal end having a substantiallytapered distal tip interior surface and a distal end interior surface ofrectangular cross-section; a plunger adapted for inserting into saidproximal end of said hollow tube, said plunger having a distal endexterior surface of rectangular cross-section contoured to said distalend interior surface of said hollow tube, said plunger having asubstantially tapered distal tip contoured to said substantially tapereddistal tip interior surface of said hollow tube to form a substantiallycongruent fit, wherein bone graft material within said hollow tube isdelivered to a graft receiving area through one or more lateral openingsnear said distal end of said hollow tube, said one or more lateralopenings substantially precluding the delivery of bone graft materialdirectly along said axis of said hollow tube, said plunger precludedfrom rotating when inserted into said hollow tube.

In another embodiment, a bone graft insertion apparatus is disclosed,the bone graft insertion apparatus comprising: a hollow tube having alength, a proximal end and a distal end, said hollow tube having arectangular cross-section, said distal end having a tapered tip interiorsurface and at least one opening; a plunger adapted for insertion withinsaid hollow tube at said proximal end of said hollow tube, said plungerhaving a rectangular cross-section end portion and a distal tipcontoured to conform to the distal end of said hollow tube, said plungerhaving a length sufficient such that when fully inserted into saidhollow tube, said plunger distal end contacts at least one opening.

In another embodiment, a bone graft insertion apparatus is disclosed,the bone graft insertion apparatus comprising: a hollow tube constructedto receive bone graft having an extended axis, a length, a proximal endand a distal end, said hollow tube having a rectangular cross-section,said distal end having a tapered tip interior surface with a terminusand two oval-shaped openings having an upper and a lower end located onopposite lateral sides of said distal end, said tapered tip extendinginto said hollow tube and said terminus positioned adjacent to saidoval-shaped openings; a plunger adapted for insertion within said hollowtube at said proximal end of said hollow tube, said plunger having arectangular cross-section end portion and a distal lower surface, saidplunger having a length sufficient such that when fully inserted intosaid hollow tube, said plunger distal lower surface contacts said hollowtube terminus at a position adjacent to said oval-shaped openings, saidplunger rectangular cross-section end portion forming a continuoussurface adjacent each of the oval-shaped openings from a positionopposite said terminus to a point extending beyond said upper end ofeach oval-shaped opening; wherein bone graft material within said hollowtube is delivered to a graft receiving area through said oval-shapedopenings of said hollow tube, said oval-shaped openings precluding thedelivery of bone graft material directly along said axis of said hollowtube, said plunger precluded from rotating when inserted into saidhollow tube; wherein said oval-shaped openings near the distal end ofsaid hollow tube are positioned within a 25% length from said distal endrelative to a total length of said hollow tube.

In one embodiment, a combination bone graft insertion and implantinsertion apparatus is disclosed, the apparatus comprising: a hollowtube constructed to receive bone graft, said hollow tube having anextended axis and a proximal end and a distal end, said hollow tubehaving a rectangular interior cross-section from said proximal end tosaid distal end; a plunger adapted for inserting into said proximal endof said hollow tube along the extended axis, said plunger having adistal end exterior surface of rectangular cross-section contoured tosaid interior cross-section of said hollow tube, said plunger with adistal exterior tip, said plunger distal end exterior surface ofrectangular cross-section forming a substantially congruent fit withsaid hollow tube rectangular interior cross-section; and an expandableimplant comprising a first plate, a second plate, a front block, a rearblock and a screw, the expandable implant configured to move the firstplate vertically from the second plate by rotation of the screw whichrotates without moving transversely with respect to either the first orthe second plate, said first plate and second plate moving in parallelupon rotation of the screw, the screw moving the front and the rearblocks so as to move the first and the second plate, the blocks definingan aperture on each lateral side of the expandable implant; wherein saidhollow tube and said plunger are configured to deliver bone graftmaterial to the expandable implant and to an adjacent surgical sitethrough at least the apertures on each lateral side of the expandableimplant.

In addition, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 4,863,476 toShepperd; U.S. Pat. No. 6,743,255 to Ferree; U.S. Pat. No. 6,773,460 toJackson; U.S. Pat. No. 6,835,206 to Jackson; U.S. Pat. No. 6,972,035 toMichelson; U.S. Pat. No. 7,771,473 to Thramann; U.S. Pat. No. 7,850,733to Baynham; U.S. Pat. No. 8,506,635 to Palmatier; U.S. Pat. No.8,556,979 to Glerum; U.S. Pat. No. 8,628,576 to Triplett; U.S. Pat. No.8,709,086 to Glerum; U.S. Pat. No. 8,715,351 to Pinto; U.S. Pat. No.8,753,347 to McCormack; U.S. Pat. No. 8,753,377 to McCormack; U.S.Design Patent No. D708,323 to Reyes; U.S. Pat. No. 8,771,360 to Jimenez;U.S. Pat. No. 8,778,025 to Ragab; U.S. Pat. No. 8,778,027 to Medina;U.S. Pat. No. 8,808,383 to Kwak; U.S. Pat. No. 8,814,940 to Curran; U.S.Pat. No. 8,821,396 to Miles; U.S. Patent Application Publication No.2006/0142858 to Colleran; U.S. Patent Application Publication No.2008/0086142 to Kohm; U.S. Patent Application Publication No.20100286779 to Thibodean; U.S. Patent Application Publication No.20110301712 to Palmatier; U.S. Patent Application Publication No.20120022603 to Kirschman; U.S. Patent Application Publication No.20120035729 to Glerum; U.S. Patent Application Publication No.20120089185 to Gabelberger; U.S. Patent Application Publication No.20120123546 to Medina; U.S. Patent Application Publication No.20120197311 to Kirschman; U.S. Patent Application Publication No.20120215316 to Mohr; U.S. Patent Application Publication No. 20130158664to Palmatier; U.S. Patent Application Publication No. 20130178940; U.S.Patent Application Publication No. 20140012383 to Triplett; U.S. PatentApplication Publication No. 20140156006; U.S. Patent ApplicationPublication No. 20140172103 to O'Neil; U.S. Patent ApplicationPublication No. 20140172106 to To; U.S. Patent Application PublicationNo. 20140207239 to Barreiro; U.S. Patent Application Publication No.20140228955 to Weiman; U.S. Patent Application Publication No.20140236296 to Wagner; U.S. Patent Application Publication No.20140236297 to Iott; U.S. Patent Application Publication No. 20140236298to Pinto.

Furthermore, by way of providing additional background and context, thefollowing references are also incorporated by reference in theirentireties for the purpose of explaining the nature of spinal fusion anddevices and methods commonly associated therewith, to include, withoutlimitation, expandable fusion cages: U.S. Pat. No. 7,803,159 toPerez-Cruet et al.; U.S. Pat. No. 8,852,282 to Farley et al.; U.S. Pat.No. 8,858,598 to Seifert et al.; U.S. Pat. No. D714,933 to Kawamura;U.S. Pat. No. 8,795,366 to Varela; U.S. Pat. No. 8,852,244 to Simonson;U.S. Patent Application Publication No. 2012/0158146 to Glerum et al.;U.S. Pat. No. 8,852,242 to Morgenstern Lopez et al.; U.S. Pat. No.8,852,281 to Phelps; U.S. Pat. No. 8,840,668 to Donahoe et al.; U.S.Pat. No. 8,840,622 to Vellido et al.; U.S. Patent ApplicationPublication No. 20140257405; U.S. Patent Application Publication No.20140257490 to Himmelberger et al.; U.S. Pat. No. 8,828,019 to Raymondet al.; U.S. Patent Application Publication No. 20140288652 to Boehm etal.; U.S. Patent Application Publication No. 20140287055 to Kunjachan;U.S. Patent Application Publication No. 20140276896 to Harper; U.S.Patent Application Publication No. 20140277497 to Bennett et al.; U.S.Patent Application Publication No. 20120029635 to Schoenhoeffer et al.;U.S. Patent Application Publication No. 20140303675 to Mishra; U.S.Patent Application Publication No. 20140303731 to Glerum; U.S. PatentApplication Publication No. 20140303732 to Rhoda et al.; U.S. Pat. No.8,852,279 to Weiman; PCT WO2012031267 to Weiman; U.S. Pat. No. 8,845,731to Weiman; U.S. Pat. No. 8,845,732 to Weiman; U.S. Pat. No. 8,845,734 toWeiman; U.S. Patent Application Publication No. 20140296985 toBalasubramanian et al.; U.S. Patent Application Publication No.20140309268 to Arnou; U.S. Patent Application Publication No.20140309548 to Merz et al.; U.S. Patent Application Publication No.20140309697 to lott et al.; U.S. Patent Application Publication No.20140309714 to Mercanzini et al.; U.S. Pat. No. 8,282,683 to McLaughlinet al.; U.S. Pat. No. 8,591,585 to McLaughlin et al; U.S. Pat. No.8,394,129 to Morgenstern Lopez et al.; U.S. Patent ApplicationPublication No. 20110208226 to Fatone et al.; U.S. Patent ApplicationPublication No. 20100114147 to Biyani; U.S. Patent ApplicationPublication No. 20110144687 to Kleiner; U.S. Pat. No. 8,852,243 toMorgenstern Lopez et al.; U.S. Pat. No. 8,597,333 to Morgenstern Lopezet al.; U.S. Pat. No. 8,518,087 to Lopez et al.; U.S. Patent ApplicationPublication No. 20120071981 to Farley et al.; U.S. Patent ApplicationPublication No. 20130006366 to Farley et al.; U.S. Patent ApplicationPublication No. 20120065613 to Pepper et al.; U.S. Patent ApplicationPublication No. 20130006365 to Pepper et al.; U.S. Patent ApplicationPublication No. 20110257478 to Kleiner et al.; U.S. Patent ApplicationPublication No. 20090182429 to Humphreys et al.; U.S. Patent ApplicationPublication No. 20050118550 to Turri; U.S. Patent ApplicationPublication No. 20090292361 to Lopez; U.S. Patent ApplicationPublication No. 20110054538 to Zehavi et al.; U.S. Patent ApplicationPublication No. 20050080443 to Fallin et al.; U.S. Pat. No. 8,778,025 toRagab et al.; U.S. Pat. No. 8,628,576 to Triplett et al; U.S. Pat. No.8,808,304 to Weiman, and U.S. Pat. No. 8,828,019 to Raymond.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may have various sizes. The sizes of the variouselements of embodiments of the present disclosure may be sized based onvarious factors including, for example, the anatomy of the implantpatient, the person or other device operating the apparatus, the implantlocation, physical features of the implant including, for example, with,length and thickness, and the size of operating site or the size of thesurgical tools being used with the device.

One or ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide the various aspects of the presentdisclosure. These materials may include, for example, stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. These materials may also include, for example, PEEK,carbon fiber, ABS plastic, polyurethane, rubber, latex, syntheticrubber, and other fiber-encased resinous materials, synthetic materials,polymers, and natural materials. The plunger element could be flexible,semi-rigid, or rigid and made of materials such as stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. Similarly, the tubular element could be flexible,semi-rigid, or rigid and made of materials such as stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. In certain embodiments, the plunger and hollow tube arecomposed of plastic and are intended for one use only and thendiscarded. In another embodiment, some or all elements of the device, orportions of some or all of the elements, are luminescent. Also, inanother embodiment, some or all elements of the device, or portions ofsome or all of the elements, include lighting elements. In anotherembodiment, the hollow tube and/or plunger are made of a substantiallytransparent material and/or are rigidly opaque.

In one embodiment of the fusion cage, the fusion cage comprises apolymer, such as PEEK, titanium and composite materials.

In one embodiment of the invention, a bone graft delivery kit isprovided that includes a hollow tube having a proximal end and a distalend, the hollow tube configured to convey graft material to a graftreceiving area in a patient, the hollow tube connected to an implant,and a plunger to facilitate moving the graft material through the hollowtube.

In another embodiment of the invention, a bone graft delivery kit isprovided that includes at least one hollow tube constructed to receivebone graft and having a proximal end and a distal end. The kit furtherincludes a funnel configured (i) to be disposed at the proximal end ofthe at least one hollow tube, (ii) to receive bone graft material and(iii) to deliver bone graft material into the at least one hollow tube.The kit also includes at least one plunger adapted for inserting intothe proximal end of the at least one hollow tube.

In another embodiment of the invention, a bone graft insertion kit isprovided that includes at least one one-piece hollow tube having alength, a proximal end, a distal end, and a rectangular interiorcross-section extending from the proximal end to the distal end. The kitfurther includes at least one one-piece plunger adapted for insertionwithin the at least one one-piece hollow tube at the hollow tubeproximal end, the at least one one-piece plunger having (i) a distal endexterior surface of rectangular cross-section forming a substantiallycongruent fit with the hollow tube rectangular interior cross-section,(ii) a distal tip contoured to conform to the hollow tube distal end and(iii) an axial length at least sufficient wherein at a least a portionof the plunger distal end is positioned adjacent to the at least onelateral opening when the at least one one-piece plunger is fullyinserted into the at least one one-piece hollow tube. The at least oneone-piece hollow tube and the at least one one-piece plunger areconfigured to deliver bone graft material to a graft receiving area.

One of ordinary skill in the art will appreciate that embodiments of thepresent disclosure may be controlled by means other than manualmanipulation. Embodiments of the present disclosure may be designed andshaped such that the apparatus may be controlled, for example, remotelyby an operator, remotely by an operator through a computer controller,by an operator using proportioning devices, programmatically by acomputer controller, by servo-controlled mechanisms, byhydraulically-driven mechanisms, by pneumatically-driven mechanisms orby piezoelectric actuators.

Embodiments of the present disclosure present several advantages overthe prior art including, for example, the speed of the procedure, theminimally invasive aspect of the procedure, the ability to introduce theimplant material to the implant site with minimal risk and damage to thesurrounding tissue, the lower risk of infection, more optimally placedimplant material, a more stable delivery device which is designed toreduce the likelihood of the implant material becoming dislodged priorto fixation, and fewer tools in a surgical site due to the integrationof several components required to provide bone graft to a bone graftreceiving area. Further, the lower profile of the device allows improvedviewing of the area intended for receipt of bone graft material, and useof a reduced set and size of elements therein provided a less expensivedevice. Also, the device disclosed provides that substantially all ofthe bone graft material may be ejected from the device and delivered tothe surgical site, rather than wasted as unretrievable matter remaininginside the device. The ability to remove substantially all of the bonegraft material is of significant benefit because the bone graft materialis expensive and/or hard to obtain.

This Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description of the Invention, and nolimitation as to the scope of the present disclosure is intended byeither the inclusion or non-inclusion of elements, components, etc. inthis Summary of the Invention. Additional aspects of the presentdisclosure will become more readily apparent from the DetailedDescription, particularly when taken together with the drawings.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.However, the Detailed Description of the Invention, the drawing figures,and the exemplary claim set forth herein, taken in conjunction with thisSummary of the Invention, define the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

FIG. 1A is a front perspective view of the device for delivering bonegraft;

FIG. 1B is a front perspective view of the plunger of the device;

FIG. 1C is a cross sectional view of a portion of the device shown inFIG. 1A;

FIG. 2 is another front perspective view of the device of FIGS. 1A and1B, showing the relationship between the tubular and plunger portions ofthe device;

FIG. 3 is a front perspective view of the device according to onealternative embodiment where the tubular portion includes a foot sectionand where the plunger portion has been fully inserted into the tubularportion;

FIG. 4 is a partial front perspective view of another alternativeembodiment of the device where the tubular portion includes a funnel atits proximal end designed to receive bone graft;

FIG. 5 is a partial front perspective view of the device according toone embodiment where the device is positioned in a disc space during asurgical operation;

FIG. 6 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember;

FIG. 7 is another front perspective view of the tubular portion of thedevice of FIG. 6 showing the second of two lateral openings at thedistal end of the tubular portion and a wedge-shaped distal end of thetubular member;

FIG. 8 is a front elevation view of the distal end of the tubularportion of the device of FIG. 6;

FIG. 9 is a bottom elevation view of the proximal end of the tubulardevice of FIG. 6;

FIG. 10A is a top plan view of the device of FIG. 6 with the plungerportion fully inserted into the tubular portion;

FIG. 10B is a left elevation view of the device of FIG. 6 with theplunger portion fully inserted into the tubular portion;

FIG. 10C is a bottom plan view of the device of FIG. 6 with the plungerportion fully inserted into the tubular portion;

FIG. 10D is a right elevation view of the device of FIG. 6 with theplunger portion fully inserted into the tubular portion;

FIG. 11A is a front perspective view of one embodiment of the fusioncage of the device, showing a tapered proximal end and medial openings;

FIG. 11B is a top plan view of the fusion cage of FIG. 11A;

FIG. 11C is a left elevation view of the fusion cage of FIG. 11A;

FIG. 11D is a rear elevation view of the fusion cage of FIG. 11A;

FIG. 12A is a front perspective view of another embodiment of the fusioncage of the device;

FIG. 12B is a front perspective view of yet another embodiment of thefusion cage of the device;

FIG. 12C is a front perspective view of yet another embodiment of thefusion cage of the device;

FIG. 13 is a front perspective view of one embodiment of the device,showing the relationship between the tubular and plunger portions wherethe tubular portion includes two lateral facing openings at the distalend of the tubular portion and a wedge-shaped distal end of the tubularmember, and a fusion cage fitting over the exterior distal end of thetubular member;

FIG. 14A is a top plan view of the device of FIG. 13 with the plungerportion fully inserted into the tubular portion and the fusion cagefully inserted over the tubular portion;

FIG. 14B is a left elevation view of the device of FIG. 13 with theplunger portion fully inserted into the tubular portion and the fusioncage fully inserted over the tubular portion;

FIG. 14C is a bottom plan view of the device of FIG. 13 with the plungerportion fully inserted into the tubular portion and the fusion cagefully inserted over the tubular portion;

FIG. 14D is a right elevation view of the device of FIG. 13 with theplunger portion fully inserted into the tubular portion and the fusioncage fully inserted over the tubular portion;

FIG. 15A is a front perspective view of another embodiment of the fusioncage of the device;

FIG. 15B is a top plan view of another embodiment of the device whereinthe fusion cage of the device includes internal ramps and locking slotsconfigured to engage locking tabs of the tubular portion, and theplunger includes a tapered tip;

FIG. 15C is a left elevation view of the fusion cage of FIG. 15B;

FIG. 15D is a front elevation view of the tubular portion of FIG. 15B;

FIG. 16 is a top plan view of another embodiment of the device with theplunger portion partial inserted into the tubular portion and the fusioncage engaged with the tubular portion via a break-off collar;

FIG. 17A is a top plan view of another embodiment of the device whereinthe fusion cage engages with a connector conduit which in turn engageswith the tubular portion;

FIG. 17B is a cross-sectional view of section A-A of FIG. 17A;

FIG. 18A is a top plan view of another embodiment of the device whereinthe tubular portion comprises a telescoping feature;

FIG. 18B is a left elevation view of the device of FIG. 18A;

FIG. 18C is a bottom plan view of the device of FIG. 18A;

FIG. 18D is a right elevation view of the device of FIG. 18A;

FIG. 19A is a top plan view of a fusion cage of an embodiment of thedevice particularly adapted for use in anterior lumbar interbody fusionprocedures;

FIG. 19B is a front elevation view of the device of FIG. 19A;

FIG. 19C is a left elevation view of the device of FIG. 19A;

FIG. 19D is a view of the device of FIG. 19A inserted between vertebrae;

FIG. 20A is a cross-sectional top plan view of a fusion cage of anembodiment of the device particularly adapted for use in direct lateralinterbody fusion procedures;

FIG. 20B is a front elevation view of the device of FIG. 20A;

FIG. 20C is a left elevation view of the device of FIG. 20A;

FIG. 20D is a view of the device of FIG. 20A inserted between vertebrae;

FIG. 21A is a front perspective view of a fusion cage of an embodimentof the device particularly adapted for use in connection withvertebrectomy procedures;

FIG. 21B is a left perspective view of the device of FIG. 21A;

FIG. 21C is a front elevation view of the device of FIG. 21A insertedinto a surgical site;

FIG. 21D is a left elevation view of the device of FIG. 21A insertedinto a surgical site;

FIG. 22 is a front perspective view of another embodiment of the devicefor delivering bone graft;

FIG. 23 is a front perspective exploded view of the device shown in FIG.22;

FIG. 24 is a top plan view of the device shown in FIG. 22;

FIG. 25 is a front elevation view of the device shown in FIG. 22;

FIG. 26 is a right elevation view of the device shown in FIG. 22;

FIG. 27 is a bottom plan view of the device shown in FIG. 22;

FIG. 28 is a cross-sectional view of section A-A of FIG. 25;

FIG. 29 is a front elevation view of the plunger element of the deviceshown in FIG. 22;

FIG. 30 is a cross-sectional view of section B-B of FIG. 29;

FIG. 31 is a cross-sectional of section C-C of FIG. 29;

FIG. 32 is a detailed front perspective view of a portion of the deviceshown in FIG. 22;

FIG. 33 is a cross-sectional view of section D-D of FIG. 32;

FIG. 34A is a bar graph describing experimental results of bone graftdelivery and disk material removed for L4-5;

FIG. 34B is a bar graph describing experimental results of bone graftdelivery and disk material removed for L5-S1;

FIG. 35A is a table describing experimental results of bone graftdelivery and disk material removed;

FIG. 35B is a graph of the table of FIG. 35A describing experimentalresults of bone graft delivery and disk material removed;

FIG. 36 is a front perspective exploded view of an integrated fusioncage and graft delivery device according to another embodiment;

FIG. 37 is a front perspective view of the device of FIG. 36;

FIG. 38 is a closed-up front perspective view of the device of FIG. 36;

FIG. 39 is a front perspective view of the ejection tool element of thedevice of FIG. 36;

FIG. 40 is a front perspective view of an integrated fusion cage andgraft delivery device according to yet another embodiment;

FIG. 41 is a closed-up front perspective view of the device of FIG. 40;

FIG. 42 is a close-up front perspective view of the ejection toolelement first end;

FIG. 43 is a cut-away cross-sectional view of the element of FIG. 42;

FIG. 44 is a close-up cut-away cross-sectional view of one embodiment ofthe integrated fusion cage and graft delivery device;

FIGS. 45A-G provide scaled views of one embodiment of the fusion cageelement of yet another embodiment of the integrated fusion cage andgraft delivery device configured to operate with the hollow tube ofFIGS. 46A-H, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E;

FIGS. 46A-H provide scaled views of one embodiment of the hollow tube(aka snap on cannula) of the integrated fusion cage and graft deliverydevice configured to operate with the fusion cage element of FIGS.45A-G, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E;

FIGS. 47A-D provide scaled views of one embodiment of the plunger (akasnap on plunger) of the integrated fusion cage and graft delivery deviceconfigured to operate with the fusion cage element of FIGS. 45A-G,hollow tube of FIGS. 46A-H, and ejection tool of FIGS. 48A-E;

FIGS. 48A-E provide scaled views of one embodiment of the ejection tool(aka cage insertion tool) of the integrated fusion cage and graftdelivery device configured to operate with the fusion cage element ofFIGS. 45A-G, hollow tube of FIGS. 46A-H and plunger of FIGS. 47A-D;

FIG. 49A is a left perspective view of an embodiment of the fusion cagewith expandable fusion cage feature, the fusion cage in an unexpandedstate;

FIG. 49B is a rear perspective view of the device shown in FIG. 49A;

FIG. 49C is a top perspective view of the device shown in FIG. 49A;

FIG. 50A is a left perspective view of the device shown in FIG. 49A, thefusion cage in an expanded state;

FIG. 50B is a rear perspective view of the device shown in FIG. 50A;

FIG. 50C is a top perspective view of the device shown in FIG. 50A;

FIG. 51 is a scaled rear perspective exploded view of an embodiment ofthe fusion cage with expandable fusion cage feature;

FIGS. 52A-E provide scaled views of the device shown in FIG. 51, thefusion cage in an unexpanded state;

FIGS. 53A-E provide scaled views of the device shown in FIG. 51, thefusion cage in an expanded state;

FIGS. 54A-F provide scaled views of the upper plate component of thedevice shown in FIG. 51;

FIGS. 55A-E provide scaled views of the front block component of thedevice shown in FIG. 51;

FIGS. 56A-F provide scaled views of the rear block component of thedevice shown in FIG. 51;

FIGS. 57A-C provide scaled views of the expansion screw component of thedevice shown in FIG. 51;

FIG. 58 is a rear perspective exploded view of another embodiment of thefusion cage with expandable fusion cage feature;

FIGS. 59A-E provide scaled views of the device shown in FIG. 58, thefusion cage in an unexpanded state;

FIGS. 60A-E provide scaled views of the device shown in FIG. 58, thefusion cage in an expanded state;

FIG. 61A is a front left perspective view of yet another embodiment ofthe fusion cage with expandable fusion cage feature, comprising avertical wedge angle feature;

FIG. 61B is a left elevation view of the device of FIG. 61A;

FIG. 62A is a front left perspective view of yet another embodiment ofthe fusion cage with expandable fusion cage feature, comprising ahorizontal wedge angle feature;

FIG. 62B is a left elevation view of the device of FIG. 62A;

FIG. 63A is a left rear perspective view of a fusion cage withexpandable fusion cage feature configured to communicate with aninstaller/impactor component according to yet another embodiment;

FIG. 63B is a close-up partial left rear perspective view of the devicesof FIG. 63A;

FIG. 64 is a left rear perspective view of the rear block component ofthe fusion cage of FIG. 63A;

FIG. 65A is a left rear perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, and the installer/impactor comprising aninstaller/impactor handle;

FIG. 65B is a left front perspective partial cross-sectional view of thedevices of FIG. 63A in the state of FIG. 65A, shown with the fusion cageand installer/impactor components in an engaged state, the devicesengaged with an expansion driver component, the installer/impactorcomponent shown in partial cross-section to partially show the expansiondriver fitted within the interior of the installer/impactor;

FIG. 66 is a left front perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, with the hollow tube component engaged with theinstaller/impactor component;

FIG. 67 is a left rear perspective view of the devices of FIG. 63A,shown with the fusion cage and installer/impactor components in anengaged state, and shown with the fusion cage and hollow tube in anengaged state;

FIG. 68A is a left rear perspective view of the devices of FIG. 63A,shown in the configuration of FIG. 67, with a removal pliers componentengaged with the hollow tube component;

FIG. 68B is a close-up partial perspective view of the devices of FIG.68A;

FIG. 69 is a left rear exploded perspective view of a fusion cage withexpandable fusion cage feature engaged with a hollow tube component anda funnel component, as configured to engage with a plunger component;

FIG. 70 is a left front partial perspective view of another embodimentof the hollow tube component configured to engage a fusion cage withexpandable fusion cage feature, the hollow tube configured with hollowtube slot and hollow tube slot aperture features;

FIG. 71 is a left rear perspective view of another embodiment of thelower plate component of a fusion cage with expandable fusion cagefeature, the lower plate configured with a plate tab feature configuredto engage the hollow tube slot and hollow tube slot aperture features ofFIG. 70;

FIG. 72 is a left front partial cross-section perspective view of thedevices of FIGS. 70 and 71, shown with the plate tab feature engagedwith the hollow tube slot and hollow tube slot aperture features;

FIG. 73 is a right rear exploded view of another embodiment of thefusion cage with expandable cage feature; and

FIG. 74 depicts the fusion cage with expandable cage feature engagedwith an angled insertion tool.

FIG. 75 is perspective view of a bone graft delivery device according tothe prior art.

FIG. 76 is a cross-sectional view of an intervertebral disc space and abone graft delivery device.

FIG. 77 is a plan view of a bone graft delivery device according to oneembodiment of the present disclosure.

FIG. 78 is a plan view of a bone graft delivery device according to oneembodiment of the present disclosure.

FIG. 79 is a perspective view of a portion of a bone graft deliverydevice according to one embodiment of the present disclosure.

FIG. 80 is a cross-sectional elevation view of a surgical site and abone graft delivery device according to one embodiment of the presentdisclosure.

FIG. 81 is a cross-sectional elevation view of a surgical site and abone graft delivery device according to one embodiment of the presentdisclosure.

FIG. 82 is a cross-sectional elevation view of a surgical site and abone graft delivery device according to one embodiment of the presentdisclosure.

FIG. 83 is an elevation view of a bone graft material and method ofpreparation according to one embodiment of the present disclosure.

FIG. 84 is a perspective view of bone graft material contemplated foruse with embodiments of the present disclosure.

To provide further clarity to the Detailed Description provided hereinin the associated drawings, the following list of components andassociated numbering are provided as follows:

-   -   1 Integrated fusion cage and graft delivery device    -   2 Hollow tube    -   3 Hollow tube first exterior surface    -   4 Opening (of Hollow tube)    -   5 Hollow tube second exterior surface    -   6 First end (of Hollow tube)    -   6A Knob    -   7 Hollow tube first distal opening    -   8 Second end (of Hollow tube)    -   8A Hollow tube cage clamp    -   8B Hollow tube cage clamp radial surface    -   9 Hollow tube distal interior ramp    -   9A Hollow tube distal interior ramp surface    -   10 Curved surface (of Hollow tube)    -   10A Curved interior surface (of Hollow tube)    -   11 Footing (of Hollow tube)    -   12 Plunger    -   13 Plunger distal first surface    -   14 Plunger distal second surface    -   15 Plunger distal third surface    -   16 Handle (of Plunger)    -   16A Plunger stop    -   17 Plunger medial portion    -   18 Second end (of Plunger)    -   19 Horizontal surface (of Plunger)    -   20 Curved surface (of Plunger)    -   30 Funnel    -   32 Sleeve (of Funnel)    -   34 Opening (of Funnel)    -   40 Disc space    -   50 Wedge-shaped Second end (of Hollow tube)    -   52 Wedge-shaped Second end (of Plunger)    -   60 Fusion Cage    -   61 Fusion cage surface texture    -   62 Fusion Cage First End    -   64 Fusion Cage Second End    -   65 Fusion Cage First Opening Pair    -   66 Fusion Cage First End Opening    -   67 Fusion Cage Second Opening Pair    -   68 Fusion Cage Medial Opening    -   69 Fusion Cage Lateral Opening    -   70 Fusion Cage Medial Surfaces    -   72 Fusion Cage Internal Ramps    -   80 Hollow Tube Locking Tabs    -   82 Fusion Cage Locking Slots    -   90 Break-off Collar    -   92 Fusion Cage Collar    -   93 Fusion Cage Collar Face    -   94 Fusion Cage Collar Cavity    -   96 Fusion Cage Tab Extension    -   97 Fusion Cage Tab Extension Latch    -   100 Connector Conduit    -   102 Connectors    -   110 ALIF Fusion Cage    -   112 ALIF Fusion Cage Portals    -   114 ALIF Fusion Cage Chamber    -   116 ALIF Fusion Cage Break-off Collar    -   120 D-LIF Fusion Cage    -   122 D-LIF Fusion Cage Portals    -   124 D-LIF Fusion Cage Chamber    -   126 D-LIF Fusion Cage Break-off Collar    -   130 Vertebrectomy Fusion Cage    -   132 Vertebrectomy Fusion Cage Porous Wall Portion    -   134 Vertebrectomy Fusion Cage Chamber    -   136 Vertebrectomy Fusion Cage Break-off Collar    -   138 Vertebrectomy Fusion Cage Impervious Wall Portion    -   140 Ejection Tool    -   142 Ejection Tool First (Proximal) End    -   143 Ejection Tool Stop    -   144 Ejection Tool Cover    -   145 Ejection Tool Cover Cavity    -   146 Spring Cover    -   147 Spring Cover Attachment    -   148 Spring    -   149 Ejection Tool Wings    -   150 Ejection Tool Wings Cavity    -   151 Ejection Tool L-cut    -   152 Ejection Tool Second (Distal) End    -   160 Ejection Tool Rod    -   200 Upper Plate    -   201 Upper Plate Front    -   202 Upper Plate Rear    -   203 Upper Plate Opening    -   204 Upper Plate Surface Texture    -   205 Upper Plate Track    -   206 Upper Plate Slot    -   209 Upper Plate Ridge    -   210 Lower Plate    -   211 Lower Plate Front    -   212 Lower Plate Rear    -   213 Lower Plate Opening    -   214 Lower Plate Surface Texture    -   215 Lower Plate Track    -   216 Lower Plate Slot    -   217 Plate Tab    -   218 Plate Nose    -   219 Lower Plate Ridge    -   220 Front Block    -   222 Front Block Upper Rail    -   224 Front Block Lower Rail    -   225 Front Block Nose    -   226 Front Block Ramp    -   227 Front Block Aperture    -   228 Block Spine    -   230 Rear Block    -   231 Rear Block Groove    -   232 Rear Block Upper Rail    -   234 Rear Block Lower Rail    -   236 Rear Block Ramp    -   237 Rear Block Aperture    -   238 Rear Block Aft    -   239 Rear Block Detent    -   240 Expansion Screw    -   242 Expansion Screw Head    -   244 Expansion Screw Tip    -   246 Expansion Screw Disk    -   250 Installer/Impactor    -   252 Installer/Impactor Tip    -   253 Installer/Impactor Aperture    -   254 Installer/Impactor Ridge    -   255 Installer/Impactor Channel    -   256 Installer/Impactor Ramp    -   258 Installer/Impactor Handle    -   260 Expansion Driver    -   268 Expansion Driver Handle    -   270 Removal Pliers    -   280 Hollow Tube External Ramp    -   282 Hollow Tube Notch    -   284 Hollow Tube Slot    -   285 Hollow Tube Slot Aperture    -   290 Cam    -   292 Nose Cone    -   294 Ramps    -   300 Adaptor    -   400 Prior Art Fusion Cage    -   400′ Modified Prior Art Fusion Cage    -   A Height of Opening (in Hollow tube)    -   B Width of Opening (in Hollow tube)

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention relates to a device and method for integrated andnear-simultaneous delivery of bone graft material and a fusion cage toany portion of a patient which requires bone graft material and/or afusion cage. Thus, for example, the foregoing description of the variousembodiments contemplates delivery to, for example, a window cut in abone, where access to such window for bone grafting is difficult toobtain because of orientation of such window, presence of muscle tissue,risk of injury or infection, etc. The integrated fusion cage and graftdelivery device is formed such that the one or more hollow tubes and/orplungers may be helpful in selectively and controllably placing bonegraft material and a fusion cage in or adjacent to such window. Theintegrated fusion cage and graft delivery device is formed to allowdelivery of bone graft material and/or a fusion cage in a directionother than solely along the longitudinal axis of the device, and in someembodiments transverse to the primary axis used by the surgeon oroperator of the device when inserting the device into a cannula or otherconduit to access the surgical site. This same concept applies to otherareas of a patient, whether or not a window has been cut in a bone, forexample in a vertebral disc space, and may be used whether this is afirst surgery to the area or a follow-up surgery. The present inventionalso contemplates the delivery of bone graft material and/or a fusioncage with or without the use of a plunger, and with or without the useof various other tools described in greater detail herein.

Referring now to FIGS. 1-33 and 36-45, several embodiments of thepresent invention are shown.

In regard to FIG. 1A, an integrated fusion cage and graft deliverydevice portion is shown, which is comprised of a hollow tubular memberor hollow tube or contains at least one inner lumen 2, which has a firstproximate end 6 (which is referred to elsewhere in this specification asthe “graspable end” of hollow tube 2), and a second distal end 8, with ageneral hollow structure therebetween. Thus, as shown in FIG. 1, thehollow tube 2 allows bone graft material to be inserted into the opening4 at the graspable end 6 of the hollow tube 2, and ultimately exitedfrom the hollow tube 2 through the second end 8. According to apreferred embodiment, the hollow tube 2 also comprises at least onesloped or curved surface 10 at or near the second end 8 of the hollowtube 2. Although a generally rectangular cross-section is depicted, thecross-section need not be limited to a generally rectangular shape. Forexample, cross-sections of an oval shape or those with at least onedefined angle to include obtuse, acute, and right angles can provide ashape in some situations that is more congruent with the size or shapeof the annulotomy of a particular disc space.

Referring now in detail to FIG. 1B, a plunger 12 is shown for use withthe hollow tube 2 of FIG. 1A. The plunger 12 is generally of the samegeometry as the hollow portion of the hollow tube 2, extending at leastthe same length of hollow tube 2. The plunger 12 may includes, asdepicted in FIG. 1B at least one knob or handle 16 for grasping by auser of the plunger 12. As with the interior of the hollow tube 2 at itssecond end 8, the plunger 12 also comprises at least one sloped orcurved surface 20 at or adjacent to a second end 18 of the plunger 12.The plunger 12 terminates in a generally flat, horizontal surface 19,which corresponds to the opening at the second end 8 of the hollow tube2 shown in FIG. 1A. Thus, in cooperation, the plunger 12 may be insertedinto the opening 4 of the hollow tube 2 shown in FIG. 1A, and extendedthe entire length of the hollow tube 2, at least to a point where thehorizontal surface 19 of plunger 12 is in communication with the secondend 8 of the hollow tube 2. This configuration permits a user to ejectsubstantially all of the bone graft material that is placed into thehollow tube 2 during a surgical procedure. One skilled in the art willappreciate that the plunger need not terminate in a generally flat,horizontal surface to effect the substantial removal of all of the bonegraft material placed into the hollow tube; more specifically, any shapethat allows conformance between the internal contour of the distal endof the hollow tube and the distal end of the plunger will effect thesubstantial removal of the bone graft material. Further details aboutthe relationship are described below in regard to FIG. 2. The proximalend 12 includes a handle 14 thereon configured to be readily gripped bya hand of a user. A rounded end 16 defines a portion of the proximal end12 most distant from the distal end 30. A neck 18 defines a portion of ahandle 14 most distant from the rounded end 16 at which the handle 14transitions into an arm 20. This arm 20 is preferably cylindrical (as isalso the handle 14) but with a smaller diameter than that of the handle14. The arm 20 extends to the distal end 30.

In the embodiment, of FIG. 1A-C, a contoured leading edge is provided onthe plunger to correspond with the internal contour of distal end of thehollow tube of the delivery device. This contoured plunger servesseveral purposes: First, it maintains the plunger in a desirablerotational position with respect to the hollow tube (i.e., prevents theplunger from inadvertently or intentionally being manipulated to rotateabout the longitudinal axis of the hollow tube). Second, it ensure thatwhen the plunger is fully inserted, the plunger removes substantiallyall of the bone graft material from the hollow tube. Also, the contouredplunger, corresponding to the contoured tubular member, allows immediateidentification of the orientation of the device, and more specificallythe direction of eject of the bone graft material into the surgicalarea. Alternative positioning means may also be provided to ensure thatthe plunger remains in the desirable position during delivery of bonegraft into the hollow tube, for example by a machined bevel or edge onthe outer surface of the plunger, and a corresponding groove in theinterior surface of the hollow tube, which must be aligned wheninserting the plunger in the hollow tube.

Referring now to FIG. 1C, an elevation view of the hollow tube 2 shownin FIG. 1A is shown in detail. The second end 8 of the hollow tube 2 hasan opening with a height A and width B according to the needs of thesurgeon, the location of the bone graft receiving area, the nature ofthe surgical operation to be performed, and the quantity and type ofbone graft that is being inserted in (and ultimately ejected from) thisintegrated fusion cage and graft delivery device. According to apreferred embodiment, the height A of the opening at the second end 8 ofthe hollow tube 2 is in the range of 4 mm to 9 mm, and in a mostpreferred embodiment is about 7 mm. According to a preferred embodiment,the width B of the opening at the second end 8 of the hollow tube 2 isin the range of 7 mm to 14 mm, and in a most preferred embodiment isabout 10 mm.

Referring to FIGS. 1A-C, it is to be understood that although theseparticular drawings reflect an embodiment where the second end 8 of thehollow tube 2, and the second end 18 of the plunger 12 comprise a curvedor sloped surface which extends at least a certain distance laterallyaway from the generally longitudinal axis of the hollow tube 2/plunger12, that in other embodiments, the second end 8 of the hollow tube 2(and thereby, the second end 18 of the plunger 12) do not extend alateral distance away, but rather terminate along the longitudinal wallof the hollow tube 2. In this embodiment, the hollow tube 2 may have asecond end 8 which has an opening that is carved out of the side of thewall of the hollow tube 2, such that it appears as a window in thetubular body of hollow tube 2. According to this embodiment, thehorizontal face 19 of the plunger 12 would also be a face on the outersurface of plunger 12, without extending any lateral distance away fromthe body of plunger 12. According to this embodiment, the plunger 12would still retain the curved or sloped surface at the opposite end ofthe horizontal face 19 (referred to in FIG. 1B as 20) and similarly thehollow tube 2 would still comprise a sloped or curved surface 10opposite the opening at second end 8. It is to be expressly understoodthat other variations which deviate from the drawing FIGS. 1A-C are alsocontemplated with the present invention, so long as that the opening atthe second end 8 of hollow tube 2 is oriented to permit bone graft to beexited from the hollow tube 2 in a generally lateral direction (inrelation to the longitudinal direction of the axis of the hollow tube2).

According to another embodiment, the plunger 12 shown in FIG. 1B mayfurther comprise a secondary handle (not shown in FIG. 1B), whichincludes an opening about at least one end of secondary handle such thatit is permitted to couple with handle 16 of plunger 12. In this fashion,the secondary handle may be larger, contain one or more rings orapertures for placing a users hand and/or fingers, or may simply be of amore ergonomic design, for accommodating use of the plunger 12 during asurgical operation. The secondary handle, according to this embodiment,is selectively removable, which permits a surgeon to use the secondaryhandle for inserting the plunger 12, and then at a later point removethe secondary handle, for instance, to improve visibility through theincision or through the hollow tube 2, and/or to determine whethersubstantially all of the bone graft material has been ejected from thehollow tube 2.

Referring now in detail to FIG. 2, the plunger 12 is shown inserted intothe hollow tube 2, such that the horizontal face 19 is substantiallyplanar with the opening at the second end 8 of the hollow tube 2. Asdescribed above, the geometry of plunger 12 is such that it fits snugglyor tightly in the interior of the hollow tube 2. This configuration issuch that the sloped or curved surface 10 of the hollow tube 2 issubstantially congruent to the sloped or curved surface 20 (not shown inFIG. 2), thereby allowing the plunger to be inserted into the hollowtube 2 and allowing substantially all of bone graft material which isplaced into the hollow tube 2 to be ejected by the user.

Referring now in detail to FIG. 3, an alternate embodiment of thepresent invention is shown. According to this embodiment, the hollowtube 2 comprises a footing 11 at the second end 8 of the hollow tube 2.This footing 11 extends in a lateral direction, opposite the directionof the opening at the second end 8 of the hollow tube 2. The purpose ofthis footing 11 is to prevent injury to the annulus of a patient, orother sensitive anatomy adjacent the bone graft receiving area. Thisfooting 11 is helpful when a surgeon or other user of the integratedfusion cage and graft delivery device is using the plunger 12 to drivebone graft through the hollow tube 2, or using another tool, such as atamp, mallet, or other driving or impacting device to strike the plunger12 and/or hollow tube 2 during the surgical procedure. Without thefooting 11, the hollow tube 2 would have a generally angular second end8, which may cause damage to the patient during these types ofprocedures. Thus, the footing 11 prevents the second end 8 of the hollowtube 2 from penetrating the annulus or other sensitive anatomy of thepatient.

According to this embodiment, the footing 11 may also operate to ensurea fixed position of the second end 8 of the hollow tube 2 in thesurgical site. This in turn allows a user to ensure that bone graftejecting the second end 8 of the hollow tube 2 is being ejectedlaterally, and in the desired direction. This may be important, forexample, when the integrated fusion cage and graft delivery device isplaced within a disc space, and bone graft is being ejected laterallyfrom the second end 8 of the hollow tube 2 in a specific direction. Inother embodiments, the footing 11 may also serve as a visual marker forthe surgeon, as it extends away from the horizontal wall of the hollowtube 2, and is therefore visible at the second end 8 of the hollow tube2. As shown in FIG. 3, the presence of the footing 11 does not affectthe interior slope or curved surface 10A of the hollow tube 2, so thatthe plunger 12 of the design shown in FIG. 1B may still be used with thehollow tube 2 of this alternate embodiment.

Referring now in detail to FIG. 4, a removable funnel 30 is shown, whichcomprises an opening 34 which is generally larger in diameter ordimension when compared to the opening 4 of the hollow tube 2. Thisremovable funnel 30 further comprises a sleeve 32, the sleeve 32 havingan internal cross-section which is substantially congruent with theexternal cross-section of the first end 6 of the hollow tube 2. Thus,according to this embodiment, the funnel 30 is selectively removablefrom the first end 6 of the hollow tube 2, and may allow a surgeon tomore easily place new or additional bone graft into the hollow tube 2 byway of the opening 34 of the funnel 30. This funnel 30 may be used inconnection with a hollow tube 2 that has been pre-filled with bonegraft, or a hollow tube which is not pre-filled with bone graft. Thus,the funnel may be selectively positioned on the first end 6 of thehollow tube 2 at any point during the surgical operation when thesurgeon desires new or additional bone graft be placed in the hollowtube 2 of the integrated fusion cage and graft delivery device.

Referring now in detail to FIG. 5, one particular application of theintegrated fusion cage and graft delivery device is shown in aperspective view. Here, the integrated fusion cage and graft deliverydevice is shown with the embodiment of the hollow tube 2 furthercomprising a footing 11, and a second end opening for ejecting bonegraft in a generally lateral direction, here in the interior of a discspace 40. The disc is shown with an opening on one end for inserting thesecond end 8 of the hollow tube 2 of the integrated fusion cage andgraft delivery device. As opposed to prior art integrated fusion cageand graft delivery devices which have an opening at a second end that isopen to the longitudinal axis of the delivery device, the presentinvention comprises a lateral opening, which as shown in FIG. 5 allows asurgeon to eject bone mill into the lateral direction and thereby intothe opened areas of the disc space 40. A surgeon has the option torotate the direction of the opening in the second end 8 of the hollowtube 2 for ejecting additional bone graft to other open areas in thedisc space 40. Once the disc space 40 is substantially full of bonegraft, the surgeon may remove the hollow tube 2 without disturbing thedisc or anatomy of the patient. The surgeon may also accomplish thedelivery of bone graft without displacing any cage or other structuralimplantable device which may be present in or adjacent the disc space.One skilled in the art will appreciate that the hollow tube 2 furthercomprising a footing 11, and a second end opening for ejecting bonegraft in a generally lateral direction, may effect the delivery of bonegraft in a lateral direction simultaneous with delivery in alongitudinal direction.

Referring now to FIGS. 6-10, a preferred embodiment of the device isshown. In regard to FIG. 6, a integrated fusion cage and graft deliverydevice portion is shown, comprised of a hollow tubular member 2, whichhas a first proximate end 6 and a second distal end 8, with a generalhollow structure therebetween. The generally hollow tube 2 is shown withone of two lateral openings at the distal end 8 of the tubular member 2viewable (the other is viewable in FIG. 7). Also in FIG. 6, the plungermember 12 is shown. The manner of insertion of plunger member 12 intotubular member 2 is also provided. Thus, as shown in FIG. 6, the hollowtube 2 allows bone graft material to be inserted into the opening 4 atthe proximal end 6 of the hollow tube 2, and ultimately exited from thehollow tube 2 through the second distal end 8 from the lateral openingsat the distal end 8 of the hollow tubular member 2.

Furthermore regarding FIG. 6, a preferred embodiment of the distal end10 of the tubular member 2 and the distal end 20 of the plunger member12 is provided. The configuration provided, a wedge-shaped end 50 of thetubular member and a wedge-shaped end of the plunger 52, allowssubstantially all of the bone graft material to be removed and thusinserted into the surgical area when the plunger 2 is fully insertedinto the tubular member 2. The wedge-shaped feature 50 of the distal end10 of the tubular member 2 and the wedge-shaped end 52 of the distal end20 of the plunger member 12 is discussed in additional detail withrespect to FIGS. 8 and 9 below. The ability to remove substantially allof the bone graft material is an important feature of the inventionbecause bone graft material is traditionally expensive and may requiresurgery to obtain.

Referring now to FIG. 7, a perspective view of a preferred embodiment ofthe hollow tubular member 2 is provided. Consistent with FIG. 6, thegenerally hollow tube 2 is shown with one of two lateral openings at thedistal end 8 of the tubular member 2 viewable (the other is viewable inFIG. 6). Thus, in operation the hollow tube 2 allows bone graft materialto be inserted into the opening 4 at the proximal end 6 of the hollowtube 2, and ultimately exited from the hollow tube 2 through the seconddistal end 8 from the lateral openings at the distal end 8 of the hollowtubular member 2. In this configuration, bone graft material is ejectedinto the surgical area in two lateral directions. One skilled in the artwill appreciate that the openings at the distal end 8 of the hollowtubular member 2 need not be positioned exclusively on one or morelateral sides of the distal end 8 of the tubular member to allow bonegraft material to be provided to the surgical site in other than apurely axial or longitudinal direction. Further, one skilled in the artwill appreciate that the specific absolute and relative geometries andnumbers of lateral openings may vary, for example the distal end 8 ofthe tubular member 2 may have more than two openings that are ofdifferent shape (e.g. oval, rectangular).

Referring now to FIG. 8, an elevation view of the wedge-shaped distalend 50 of the tubular member 2 is provided. In this embodiment, theproximal end of the plunger would conform to the same shape, to allowclose fitting of the plunger and the hollow tubular member. Thiscontoured plunger, corresponding to the contoured tubular member, servesseveral purposes: First, it maintains the plunger in a desirablerotational position with respect to the hollow tube (i.e., prevent theplunger from inadvertently or intentionally being manipulated to rotateabout the longitudinal axis of the hollow tube); Second, it ensure thatwhen the plunger is fully inserted, the plunger removes substantiallyall of the bone graft material from the hollow tube. Also, the contouredplunger, corresponding to the contoured tubular member, allows immediateidentification of the orientation of the device, and more specificallythe direction of eject of the bone graft material into the surgicalarea. One skilled in the art will appreciate that the plunger need notterminate in a wedge-shape surface to effect the substantial removal ofall of the bone graft material placed into the hollow tube; morespecifically, any shape that allows conformance between the internalcontour of the distal end of the hollow tube and the distal end of theplunger will effect the substantial removal of the bone graft material.

Referring now to FIG. 9, an elevation view of the opening 4 of thedistal end 6 of the hollow tubular member 2 is provided. As shown inFIG. 9, the opening 4 at the proximal end 6 of the hollow tube 2 allowsdeposit of bone graft material. In this configuration, the cross-sectionof the opening 4 at the proximal end 6 of the hollow tube 2 is generallysquare. Although a generally square cross-section is depicted, thecross-section need not be limited to a generally square shape. Forexample, cross-sections of an oval shape or those with at least onedefined angle to include obtuse, acute, and right angles can provide ashape in some situations that is more congruent with the size or shapeof the annulotomy of a particular disc space.

Referring to FIGS. 10A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting the complete insertion of theplunger 12 into the hollow tubular member 2. In each of FIGS. 10A-D, thewedge-shaped distal end 50 of the tubular member 2 is depicted. Also,each of FIGS. 10A-D depict the additional length of the plunger element12 when inserted into the tubular member 2. FIG. 10A shows one of twolateral openings at the distal end 8 of the hollow tubular member 2.FIG. 10C shows another of the two lateral openings at the distal end 8of the hollow tubular member 2. One skilled in the art will appreciatethat the openings at the distal end 8 of the hollow tubular member 2need not be positioned exclusively on one or more lateral sides of thedistal end 8 of the tubular member to allow bone graft material to beprovided to the surgical site in other than a purely axial orlongitudinal direction. Further, one skilled in the art will appreciatethat the specific absolute and relative geometries and numbers oflateral openings may vary, for example the distal end 8 of the tubularmember 2 may have more than two openings that are of different shape(e.g. oval, rectangular).

Referring to FIGS. 11A-D, a fusion cage 60 of an integrated fusion cageand graft delivery device 1 portion is shown, which is comprised of aintegrated fusion cage 60 that comprises a first proximal end 62 and asecond distal end 64 wherein the first proximal end contains an opening66 adapted to allow fitting and/or engagement to the distal end 8 of thehollow tube 2. This fitting and/or engagement may be over the externalsurface of the hollow tube 2 or inside the interior of the hollow tube2. Further, the integrated fusion cage 60 may comprise one or moremedial openings 68 that align with one or more openings at the distalend 8 of the hollow tube 2. Further, the integrated fusion cage 60 maycontain non-smooth surfaces, such as belts or striations, along one ormore medial surfaces 70 of the integrated fusion cage 60. The integratedfusion cage 60 is configured such that when a plunger 12, once fullyinserted in to the hollow tube 2, is substantially congruent with thehollow interior portion of the hollow tube 2, e.g. both the plunger 12and the hollow tube 2 are substantially the same shape and/or class andbone graft material is delivered through the integrated fusion cage 60into the surgical area.

In a preferred embodiment, the fusion cage 60 has a tapered tip, andseveral open channels along the medial and lateral surfaces. In apreferred embodiment, the fusion cage 60 and/or the bone graft deliveryportion of the integrated fusion cage and graft delivery device is ofoblong or rectangular or square shape. The integrated fusion cage andgraft delivery device 1 is designed to avoid blocking or impacting bonegraft material into a surgical disc space, thereby limiting the bonegraft material that may be delivered, and not allowing available fusionspace to be fully exploited for fusion.

In a preferred embodiment, the fusion cage 60 has a keel-shaped tip toseparate disk and prevent annular penetration. Also, the fusion cage 60may have dual portals for bone graft discharge, with the medial openings68 larger than the lateral openings 69. Further, the fusion cage may bedesigned in variable heights and lengths so that it fits snugly into theprepared disk space.

Referring now to FIGS. 12A-C, two alternate embodiments of the fusioncage 60 are provided. FIG. 12A shows an embodiment of the integratedfusion cage 60 with a second distal end 64 tapered to a flat rectangularshape end. FIG. 12B shows an embodiment of the integrated fusion cage 60with a second distal end 64 tapered to a wedged-shaped end. Such aconfiguration would be, for example, would be conformal with thewedge-shaped second end 50 of the hollow tube 2, as shown in FIGS. 6-8.FIG. 12C shows an embodiment of the integrated fusion cage 60 with beltsof striations imparted to the upper medial surface 70 of the fusion cage60.

In regard to FIG. 13, an integrated fusion cage and graft deliverydevice 1 is shown, comprised of a hollow tubular member 2, which has afirst proximate end 6 and a second distal end 8, with a general hollowstructure therebetween. The generally hollow tube 2 is shown with one oftwo lateral openings at the distal end 8 of the tubular member 2viewable. Also in FIG. 13, the plunger member 12 is shown and the fusioncage 60. The manner of insertion of plunger member 12 into tubularmember 2 is also provided, as is the manner of insertion of fusion cage60 over tubular member 2 and into the fusion cage first end opening 66.Thus, as shown in FIG. 13, the hollow tube 2 allows bone graft materialto be inserted into the opening 4 at the proximal end 6 of the hollowtube 2, and ultimately exited from the hollow tube 2 through the seconddistal end 8 from the lateral openings at the distal end 8 of the hollowtubular member 2 and through the medial openings 68 and/or the lateralopenings 69 of the fusion cage 60. In one embodiment as shown in FIG.13, the lateral openings at the distal end 8 of the hollow tubularmember 2 are preferably disposed within a distance from the distal end 8not exceeding 25% of the total distance (or length) of the hollow tubemember 2, more preferably not exceeding 15% of this identified distance,and most preferably not exceeding 10% of this identified distance. Inone embodiment as shown in FIG. 13, the lateral openings at the distalend 8 of the hollow tubular member 2 are preferably disposed within adistance from the distal end 8 not exceeding 10 cm of the total distance(or length) of the hollow tube member 2, more preferably not exceeding 8cm of this identified distance, and most preferably not exceeding 5 cmof this identified distance.

Referring to FIGS. 14A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting sequential elevation views ofthe integrated fusion cage and graft delivery device 1 with the plungerportion 12 fully inserted into the tubular portion 2 and the fusion cage60 fully inserted over the tubular portion 2. One skilled in the artwill appreciate that the openings at the distal end 8 of the hollowtubular member 2 need not be positioned exclusively on one or morelateral sides of the distal end 8 of the tubular member to allow bonegraft material to be provided to the surgical site in other than apurely axial or longitudinal direction. Further, one skilled in the artwill appreciate that the specific absolute and relative geometries andnumbers of lateral and medial openings may vary, for example the distalend 8 of the tubular member 2 may have more than two openings that areof different shape (e.g. oval, rectangular).

Referring to FIGS. 15A-D, a fusion cage 60 of an integrated fusion cageand graft delivery device portion is shown, which is comprised of aintegrated fusion cage 60 that comprises a first proximal end 62 and asecond distal end 64 wherein the first proximal end contains an opening66 adapted to allow fitting and/or engagement to the distal end 8 of thehollow tube 2. This fitting and/or engagement may be over the externalsurface of the hollow tube 2 or inside the interior of the hollow tube2. Further, the integrated fusion cage 60 may contain non-smoothsurfaces, such as belts or striations, along one or more medial surfaces70 of the integrated fusion cage 60. The integrated fusion cage 60 isconfigured such that when a plunger 12, once fully inserted in to thehollow tube 2, is substantially congruent with the hollow interiorportion of the hollow tube 2, e.g. both the plunger 12 and the hollowtube 2 are substantially the same shape and/or class and bone graftmaterial is delivered through the integrated fusion cage 60 into thesurgical area.

In a preferred embodiment, the fusion cage 60 has a tapered tip, andseveral open channels along the medial and lateral surfaces. In apreferred embodiment, the fusion cage 60 is of a square shape and thebone graft delivery portion of the integrated fusion cage and graftdelivery device is of a cylindrical shape. The integrated fusion cageand graft delivery device 1 is designed to avoid blocking or impactingbone graft material into a surgical disc space, thereby limiting thebone graft material that may be delivered, and not allowing availablefusion space to be fully exploited for fusion.

In a preferred embodiment, the fusion cage 60 has a keel-shaped tip toseparate disk and prevent annular penetration and has internal ramps 72which assist in directing the bone graft material to one or more lateralopenings 69. As the plunger 12 is inserted into the hollow tube 2, bonegraft material is directed by the fusion cage internal ramps 72 out thelateral openings 69, and bone additionally bone graft material may flowout the one or more medial openings 68. The plunger end 18 may beconfigured to be conformal with the internal ramps 72 of the fusion cage60, as depicted in FIG. 15B. Also, the fusion cage 60 may have dualportals for bone graft discharge, with the medial openings 68 largerthan the lateral openings 69. Further, the fusion cage may be designedin variable heights and lengths so that it fits snugly into the prepareddisk space.

In a preferred embodiment as shown in FIGS. 15B-D, the hollow tube 2 isof cylindrical shape and includes one or more locking tabs 80 configuredto engage one or more locking slots 82 of the fusion cage 60. Thelocking tabs 80 may permanently or not permanently engage the lockingslots 82, and may be of shape to include rectangular, circular andoblong. The instruments used with the integrated fusion cage and graftdelivery device described above in its varying embodiments may includeone or more tamps, preferably having a configuration which at least inpart corresponds in shape and contour of the hollow tube portion of thedelivery device. The one or more tamps may be adapted to correspondfurther to the shape and contour of the graspable end of the plunger,for use in driving the plunger through the hollow tube portion of thedelivery device to ensure any remaining bone graft located in the hollowtube is delivered to the graft receiving area.

In the embodiment of the device of FIG. 16, the hollow tube 2 engageswith the fusion cage 60 via a break-off collar 90 and the plunger 12inserts into the interior of the hollow tube 2. The plunger 12 isdepicted partially inserted into the hollow tube 2. The break-off collar90 may be severed by any of several means, to include application oftorsion and/or rotational force and/or lateral force to break-off collar90, for example by twisting on the hollow tube 2 and/or the plunger 12.

In the embodiment of the device of FIG. 17A-B, the hollow tube 2 engageswith a connector conduit 100 which in turn connects with the fusion cage60 via a break-off collar 90. One or more connectors 102 connect thehollow tube 2 with the connector conduit 100. The hollow tube 2 fitsover the connector conduit 100. The one or more connectors 102 fitthrough the hollow tube 2 and the connector conduit 100. The break-offcollar 90 may be severed by any of several means, to include applicationof torsion and/or rotational force and/or lateral force to break-offcollar 90, for example by twisting on the hollow tube 2 and/or theplunger 12. In one embodiment of the connector conduit 100, as shown inFIG. 17B, the connector conduit 100 is of circular cross-section.

Referring to FIGS. 18A-D, sequential elevation views of thesquare-shaped embodiment of the integrated fusion cage and graftdelivery device 1 are provided, depicting sequential elevation views ofthe integrated fusion cage and graft delivery device 1 with telescopingtubular portion 2 and the fusion cage 60 fully inserted over the tubularportion 2. One skilled in the art will appreciate that the openings atthe distal end 8 of the hollow tubular member 2 need not be positionedexclusively on one or more lateral sides of the distal end of thetubular member to allow bone graft material to be provided to thesurgical site in other than a purely axial or longitudinal direction.

In an embodiment of the invention particularly suited for ALIFprocedures, a fusion cage 110 as shown in FIGS. 19A-D comprises a hollowinternal chamber 114 in fluid communication with bone graft dischargeportals 112 and a charging portal 116, which comprises a break-offcollar in some embodiments such as those depicted in FIGS. 17A-D. Thefusion cage 110 has a substantially cylindrical shape, with thedischarge portals 112 located opposite each other on the curved lateralportion of the fusion cage 110 and the charging portal 116 locatedsubstantially in between the discharge portals 112 on the curvedanterior portion of the fusion cage 110. The curved posterior portion ofthe fusion cage 110 is substantially devoid of portals from the internalchamber 114 to the exterior of the fusion cage 110. The charging portal116 is adapted to receive a hollow tube such as the hollow tube 2 shownin other embodiments described herein. Bone graft material enters theinternal chamber 114 through a hollow tube connected to the chargingportal 116, and exits the internal chamber 114 through the dischargeportals 112. The discharge portals 112 are positioned so that when thefusion cage 110 is properly positioned in between two vertebrae, bonegraft material discharged therethrough fills the space in between thevertebrae on the lateral sides of the spine, but does not discharge intoor fill the anterior or posterior space in between the vertebrae. Inembodiments of fusion cage 110 comprising a break-off collar, once thefusion cage 110 is properly positioned and the desired amount of bonegraft material has been inserted into the chamber 114 and dischargedthrough the discharge portals 112, the break-off collar is severed fromthe fusion cage 110 (as described with respect to other embodimentsherein) and removed from the patient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 116 of fusion cage 110 is adapted to removably receive a hollowtube (such as the hollow tube 2 shown in other embodiments describedherein). For example, the walls of the charging portal 116 may bethreaded so that the hollow tube can be screwed into the charging portal116.

The fusion cage 110 preferably has a height of from about 8 millimetersto about 14 millimeters, and a diameter of less than about 36millimeters. The fusion cage 110 is made from polyether ether ketone(PEEK), titanium, a composite material, or any other material suitablefor implantation in a human body. The fusion cage 110 comprises, in someembodiments, ramps within internal chamber 114 to guide bone graftmaterial to discharge portals 112.

In an embodiment of the invention particularly suited for D-LIFprocedures, a fusion cage 120 as shown in FIGS. 20A-D comprises a hollowinternal chamber 124 in fluid communication with bone graft dischargeportals 122 and a charging portal 126, which in someembodiments—including the embodiment shown in FIGS. 20A-D—comprises abreak-off collar. The fusion cage 120 is substantially shaped as arectangular prism, with the discharge portals 122 located on oppositesides of the fusion cage 120 and the charging portal 126 located on alateral face of the fusion cage 120. The opposite lateral face of thefusion cage 120 is devoid of portals from the internal chamber 124 tothe exterior of the fusion cage 120. The charging portal 126 is adaptedto receive a hollow tube such as the hollow tube 2 shown in otherembodiments described herein. Bone graft material enters the chamber 124through a hollow tube connected to the charging portal 126, and exitsthe internal chamber 124 through the discharge portals 122. Thedischarge portals 122 are positioned so that when the fusion cage 120 isproperly positioned in between two vertebrae, bone graft materialdischarged therethrough fills the space in between the vertebrae towardsthe anterior and posterior of the spine, but does not discharge into orfill the lateral space in between the vertebrae. As with otherembodiments described herein, in embodiments that comprise a break-offcollar, once the fusion cage 120 is properly positioned and the desiredamount of bone graft material has been inserted into the chamber 124through charging portal 126 and discharged through the discharge portals122, the break-off collar is severed from the fusion cage 120 (asdescribed with respect to other embodiments herein) and removed from thepatient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 126 is adapted to removably receive a hollow tube (such as thehollow tube 2 shown in other embodiments described herein). For example,the internal walls of charging portal 126 may be threaded so that thehollow tube can be screwed into the charging portal 126.

The fusion cage 120 preferably has a height of from about 8 millimetersto about 14 millimeters, and a length of from about 22 millimeters toabout 36 millimeters. The fusion cage 120 is made from polyether etherketone (PEEK), titanium, a composite material, or any other materialsuitable for implantation in a human body. The fusion cage 120comprises, in some embodiments, ramps within internal chamber 124 toguide bone graft material to discharge portals 122.

Referring now to FIGS. 21A-D, in embodiments of the inventionparticularly suited for use in connection with a vertebrectomy, a fusioncage 130 comprises a substantially cylindrical wall surrounding aninternal chamber 134. Thus, the fusion cage 130 has a substantiallycylindrical shape. Internal chamber 134 is open at the top and thebottom of fusion cage 130, and lateral portions 132 of the cylindricalwall of the fusion cage 130 are porous to bone graft material (i.e. bonegraft slurry). Anterior and posterior portions 138 of the cylindricalwall of fusion cage 130 in between porous portions 132 are impervious tobone graft material. A charging portal 136—which in some embodiments,including the embodiment shown in FIGS. 21A-D, comprises a break-offcollar—is positioned on an impervious portion 138 of fusion cage 130.The charging portal 136 is adapted to receive a hollow tube such as thehollow tube 2 shown in other embodiments described herein. Bone graftmaterial enters the chamber 134 through a hollow tube connected to thecharging portal 136, and exits the chamber 134 through porous wallportions 132. The porous wall portions 132 are positioned so that whenthe fusion cage 130 is properly positioned in between two vertebrae,bone graft material discharged therethrough fills the space in betweenthe vertebrae on either side of the spine, but the impervious wallportions 138 prevent bone graft material from discharging into theanterior or posterior space in between the vertebrae, thus preventingbone graft material from pushing against the spinal cord. In embodimentsof fusion cage 130 comprising a break-off collar, once the fusion cage130 is properly positioned and the desired amount of bone graft materialhas been inserted into the chamber 134 through charging portal 136 anddischarged through the porous wall portions 132, the break-off collar136 is severed from the fusion cage 130 (as described with respect toother embodiments herein) and removed from the patient's body.

In embodiments that do not comprise a break-off collar, the chargingportal 136 is adapted to removably receive a hollow tube (such as thehollow tube 2 shown in other embodiments described herein). For example,the internal walls of the charging portal 136 may be threaded so thatthe hollow tube can be screwed into the charging portal 136.

The fusion cage 130 preferably has a height equal to or greater than thevertebra or vertebrae it is intended to replace, and a diameter of lessthan about 36 millimeters. The fusion cage 130 is made of polyetherether ketone, titanium, a composite material, or any other materialsuitable for implantation in a human body. In some embodiments, ramps inthe internal chamber 134 guide the bone graft material to the porouslateral faces 132.

Referring now to FIGS. 22-33, another embodiment of the device fordelivering bone graft is provided. In regard to FIGS. 22-28, integratedfusion cage and graft delivery device 1 is shown. FIG. 22 is aperspective view of the device 1, FIG. 23 a perspective exploded view,FIG. 24 a top plan view, FIG. 25 a front elevation view, FIG. 26 a rightelevation view, FIG. 27 is a bottom plan view, and FIG. 28 is across-sectional view of section A-A of FIG. 25.

Device 1 is comprised of a hollow tubular member or hollow tube 2, aplunger 12 which fits within the hollow tube 2, and a funnel 30. Thefunnel 30 engages the upper or distal or first end 6 of the hollow tube,and comprises a sleeve 32 and opening 34. Medical material, such as bonegraft material, is inserted into opening 34 of funnel 30, which in turnenters hollow tube 2. Hollow tube 2 comprises hollow tube first exteriorsurface 3, hollow tube second exterior surface 5, first end 6, secondend 8, and hollow tube first distal opening 7. Hollow tube 2 isgenerally of symmetrical shape such that first exterior surface 3comprises two such surfaces opposite or at 180 degrees from one another,and second exterior surface 5 comprises two such surfaces opposite or at180 degrees from one another. Also, hollow tube first distal opening 7is positioned on each of two opposite sides of hollow tube 2 at secondend 8, each opening from hollow tube first exterior surface 3.

Funnel 30 is configured with sleeve 32 such that funnel 30 may bepositioned at second end 8 of hollow tube 2 such that hollow tube mayfit through funnel 30, enabling funnel 30 to move along hollow tube 2from second end 8 of hollow tube 2 to first end 6 of hollow tube 2 untilfunnel 30 engages first end 6 of hollow tube, such as at protrusion orshelf depicted in FIG. 23.

Plunger 12 comprises handle 16 at upper or proximal end of plunger 12,plunger distal or second end 18. Plunger second end 18 comprises distalfirst surface 13, distal second surface 14 and distal third (or bottom)surface 15. Plunger second end 18 is generally of symmetrical shape suchthat distal first surface 13 comprises two such surfaces opposite or at180 degrees from one another, and distal third surface 15 comprises twosuch surfaces opposite or at 180 degrees from one another. Plunger 12 isconfigured such that second end 18 forms a congruent or conformalengagement with the interior of the hollow tube 2. Stated another way,the plunger second end 18 fits within the hollow tube 2 so as to slidewithin the hollow tube with minimal to no effective spacing between theexterior surface of the plunger second end 18 and the interior of thehollow tube 2, thereby forcing through bone graft material positioned inthe hollow tube 2 through the hollow tube when the plunger 12 (and thusits second end 18) is axially moved from hollow tube first end 6 tohollow tube second end 8.

In regard to FIGS. 29-31, further features of the plunger 12 aredescribed. FIG. 29 is a front elevation view of the plunger element ofthe device shown in FIG. 22, FIG. 30 is a cross-sectional view ofsection B-B of FIG. 29, and FIG. 31 is a cross-sectional of section C-Cof FIG. 29. Plunger 12 comprises handle 16 at upper or proximal end ofplunger 12, plunger distal or second end 18. Plunger second end 18comprises distal first surface 13, distal second surface 14 and distalthird (or bottom) surface 15. Plunger medial portion 17 forms a crossconfiguration, as depicted in FIG. 30, such that distal first surfaces13 are of reduced width relative to width at second end 18. Similarly,plunger distal second surfaces 14, at plunger medial portion 17, are ofreduced width relative to width at second end 18. At distal end 18 ofplunger 12, plunger cross-section is a rectangle, as depicted in FIG.31.

In regard to FIGS. 32 and 33, additional detail of the distal portion ofdevice 1 are provided. FIG. 32 is a detailed view of a portion of thedevice 1 shown in FIG. 22 and FIG. 33 is a cross-sectional view ofsection D-D of FIG. 32. Each of FIGS. 32 and 33 depict the device 1 whenthe plunger 12 is fully inserted into the hollow tube 2, and the plungerdistal third surface 15 has engaged and is in contact with the hollowtube distal interior ramp 9. Hollow tube distal interior ramp 9comprises hollow tube distal interior ramp surfaces 9A, symmetricallypositioned about the middle of the hollow tube second end 8. Hollow tubedistal interior ramp surfaces 9A are of curvilinear shape forming aterminus, and urge bone graft material, when disposed within the hollowtube 2, to substantially exit the pair of first distal openings 7 of thedevice 1.

Referring now to FIGS. 36-39 another embodiment of an integrated fusioncage and graft delivery device 1 is provided. With reference to FIGS.36-39, the integrated fusion cage and graft delivery device 1 comprisesplunger 12, hollow tube 2, fusion cage 60 and ejection tool 140. Thefusion cage 60 comprises fusion cage second or distal end 64 withtapered end feature and fusion cage first or proximal end 62 comprisingfusion cage collar 92, fusion cage collar face 93 and fusion cage collarcavity 94. Hollow tube 2 comprises hollow tube second end 8 whichengages fusion cage collar 92 by fitting over fusion cage collar 92 in apress or interference fit. Plunger 12 fits within hollow tube 12, andfurther may optionally fit within fusion cage collar cavity 94 so as toenter into interior of fusion cage 60 as previously described above.

Ejection tool 140 comprises ejection tool second or distal end 152 andejection tool first or proximal end 142. Ejection tool second end 152engages fusion cage collar face 93 to apply force or push fusion cage 60from engagement with hollow tube 2. Ejection tool second end 152 isconfigured such that it may not travel past or into the fusion cage.When sufficient axial force is applied to the ejection tool 140 in thedirection of the fusion cage 60, the interference fit that secures thefusion cage 60 (at fusion cage collar 92) to hollow tube 2 (at secondend 8 of hollow tube) is overcome and the fusion cage 60 is released ordisengaged from the hollow tube 2. Ejection tool 140 further comprisesan ejection tool L-cut 151 that engages knobs 6A of hollow tube 2. Inone embodiment, knobs 6A of hollow tube 2 are configured to additionallyor alternatively engage L-cuts of the funnel 30 at funnel sleeve 32 (SeeFIG. 23). Plunger 16 further comprises handle 16 and plunger stop 16Awhich engages upper portion of hollow tube 2. Plunger stop 16A may beconfigured to prevent plunger distal most portion from entering fusioncage collar cavity 94 and therefore further prevent entry into interiorof fusion cage 60.

Fusion cage 60 further comprises fusion cage internal ramps 72 asdescribed above. The fusion cage internal ramps 72 may be symmetricalabout a centerline of the device 1, and may be linear or slopedinwardly. In one embodiment, plunger stop 16A may be configured toprevent plunger distal most portion from striking or contacting fusioncage internal ramps 72 but otherwise allowing entry into fusion cagecollar cavity 94 and therefore also allow entry into interior of fusioncage 60.

Fusion cage 60 further comprises fusion cage first opening or port pair65 and fusion cage second opening or port pair 67. Fusion cage firstopening pair 65 are symmetric about a vertical plane intersecting acenterline of the fusion cage 60, and are located such that at least aportion of the openings are adjacent the tip of the fusion cage internalramps 72. The fusion cage first opening pair 65 are of an oblongracetrack shape, but in other embodiments may be oval, circular andrectangular. The fusion cage second opening pair 67 are of an ovalshape, but in other embodiments may be oblong racetrack, circular andrectangular. The fusion cage may have rounded or no square edges, andmay have a non-smooth exterior surface or any or all portions. That is,the fusion cage 60 may have ridges, bumps, contours, sawtooth profileedges along or on top of any or all exterior surfaces, such as surfacesadjacent the fusion cage second opening pair 67 and/or fusion cage firstopening pair 65.

Referring now to FIGS. 40-41, another embodiment of an integrated fusioncage and graft delivery device 1 is provided. FIG. 40 is a frontperspective view of an integrated fusion cage and graft delivery device1, and FIG. 41 is a closed-up front perspective view of a portion of thedevice of FIG. 40. The embodiment of FIGS. 40-41 comprises a pair offusion cage tab extensions 96, each of which comprises a fusion cage tabextension latch 97. Integrated fusion cage and graft delivery device 1comprises plunger 12, hollow tube 2 and fusion cage 60. FIG. 40 depictsthe integrated fusion cage and graft delivery device 1 with plunger 12fully inserted into hollow tube 2 such that plunger stop 16A engagesupper portion of hollow tube 2. The fusion cage 60 comprises fusion cagesecond or distal end 64 with tapered end feature and fusion cage firstor proximal end 62 comprising fusion cage collar 92, fusion cage collarface 93 and fusion cage collar cavity 94.

Fusion cage 60 further comprises fusion cage internal ramps 72 asdescribed above. The fusion cage internal ramps 72 may be symmetricalabout a centerline of the device 1, and may be linear or slopedinwardly. Fusion cage 60 further comprises fusion cage first opening orport pair 65 and fusion cage second opening or port pair 67. Fusion cagefirst opening pair 65 are symmetric about a vertical plane intersectinga centerline of the fusion cage 60, and are located such that at least aportion of the openings are adjacent the tip of the fusion cage internalramps 72. The fusion cage first opening pair 65 are of an oblongracetrack shape, but in other embodiments may be oval, circular andrectangular. The fusion cage second opening pair 67 are of an ovalshape, but in other embodiments may be oblong racetrack, circular andrectangular. The fusion cage may have rounded or no square edges. Fusioncage 60 has fusion cage surface texture 61, depicted as a series oflateral sawtooth-like ridges.

Fusion cage tab extensions 96, each of which comprises a fusion cage tabextension latch 97, function, among other things, to increase stabilityof the interface or connection between the distal end of the hollow tube2 and the fusion cage 60. The fusion cage tab extension latches 97 maybe configured to engage corresponding grooves on the interior surface ofthe hollow tube 2. The fusion cage tab extensions 96 fit inside the endof the hollow tube and, in one embodiment, provide a force directedoutwards to or against the interior of the hollow tube. The verticalheight and longitudinal (axial) length of the fusion cage tab extensions96 provide more secure fit between the hollow tube 2 and the fusion cage60 by restricting rotational movement, for example, of the hollow tube 2with respect to the fusion cage 60. After bone graft material isprovided to the fusion cage 60 by way of the plunger 12 (as describedabove), the fusion cage tab extensions 96 may be broken-off byapplication of a tool, such as the ejection tool 140, engaged with thefusion cage tab extension latches 97 so as to fatigue or otherwisesevere the fusion cage tab extensions 96.

Referring now to FIGS. 42-43, another embodiment of the ejection tool140 of an integrated fusion cage and graft delivery device 1 isprovided. FIG. 42 is a close-up front perspective view of the ejectiontool first end 142, and FIG. 43 is a cut-away cross-sectional view ofFIG. 42. Ejection tool 140 comprises ejection tool cover 144 whichengages ejection tool wings 149. Ejection tool 140 engages with hollowtube 2 at hollow tube knobs 6A via ejection tool L-cuts 151. Ejectiontool cover 144 comprises cylindrically-shaped ejection tool cover cavity145 which fits over cylindrically-shaped ejection tool wings cavity 150and over spring cover 146. Spring cover is secured to ejection toolcover 144 by spring cover attachment 147, which may be a pin, a screw orother means known in the art, and further fits around at least a portionof coiled spring 148. When ejection tool cover 144 is pushed downwardtoward fusion cage 60, the spring 148 compresses and imparts a force inthe opposite direction, thereby returning the ejection tool cover 144 toits original (retracted) position. In use, after securing the ejectiontool first end 142 to hollow tube 2 as described above, the user (e.g.surgeon) squeezes the ejection tool cover 144 against the ejection toolwings 149, thereby advancing the ejection tool rod 160 downwards insidethe hollow tube so as to engage the fusion cage 60 at the fusion cagecollar face 93 and release or disengage the fusion cage 60 from thehollow tube 2. The injection tool 140 and hollow tube 2 may then beremoved from the surgical site (e.g. spinal disk space) as one unit,leaving the fusion cage in the surgical site.

FIG. 44 is a close-up cut-away cross-sectional view of one embodiment ofthe integrated fusion cage and graft delivery device 1. FIG. 44 depictsa configuration of the integrated fusion cage and graft delivery device1 wherein the plunger 12 is configured to traverse the length of thehollow tube 2, past the fusion cage collar 92 and into the fusion cage60, stopping just prior to engaging the tip of the fusion cage internalramps 72. Fusion cage 60 is depicted with fusion cage first opening pair65 and fusion cage second end 64.

FIGS. 45-48 are scaled drawings of, respectively, the fusion cage 60,the hollow tube 2, the plunger 12 and the ejection tool 140 of yetanother embodiment of the integrated fusion cage and graft deliverydevice 1, and operate in coordination with one another.

FIGS. 45A-G provide scaled views of one embodiment of the fusion cageelement of yet another embodiment of the integrated fusion cage andgraft delivery device configured to operate with the hollow tube ofFIGS. 46A-H, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E.Fusion cage 60 comprises fusion cage second or distal end 64 withtapered end feature and fusion cage first or proximal end 62 comprisingfusion cage collar 92, fusion cage collar face 93 and fusion cage collarcavity 94. Fusion cage 60 further comprises fusion cage first opening orport pair 65, fusion cage second opening or port pair 67, fusion cagesurface texture 61 and fusion cage internal ramps 72.

FIGS. 46A-H provide scaled views of one embodiment of the hollow tube(aka snap on cannula) of the integrated fusion cage and graft deliverydevice configured to operate with the fusion cage element of FIGS.45A-G, plunger of FIGS. 47A-D and ejection tool of FIGS. 48A-E. Hollowtube 2 comprises first end 6 with knobs 6A and second end 8 comprisinghollow tube cage clamp 8A and hollow tube cage clamp radial surface 8B.Hollow tube cage clamp radial surface 8B is configured to engage fusioncage collar 92, for example by an interference or friction fit (i.e. to“snap-on”). Other means of connection comprise those known to thoseskilled in the art, such as a threaded-screw engagement and a tongue andgroove engagement.

FIGS. 47A-D provide scaled views of one embodiment of the plunger (akasnap on plunger) of the integrated fusion cage and graft delivery deviceconfigured to operate with the fusion cage element of FIGS. 45A-G,hollow tube of FIGS. 46A-H, and ejection tool of FIGS. 48A-E. Plunger 12comprises handle 16, plunger stop 16A, plunger medial portion 17 andsecond end 18. Second end 18 may be configured to pass into and/orthrough fusion cage collar cavity 94.

FIGS. 48A-E provide scaled views of one embodiment of the ejection tool(aka cage insertion tool) of the integrated fusion cage and graftdelivery device configured to operate with the fusion cage element ofFIGS. 45A-G, hollow tube of FIGS. 46A-H and plunger of FIGS. 47A-D.Ejection tool 140 comprises ejection tool second or distal end 152,ejection tool first or proximal end 142 and ejection tool stop 143.Ejection tool second end 152 engages fusion cage collar face 93 to applyforce or push fusion cage 60 from engagement with hollow tube 2.Ejection tool second end 152 is configured such that it may not travelpast or into the fusion cage.

A method of use of the integrated fusion cage and graft delivery device1 as depicted in any of the afore-mentioned embodiments of FIGS. 37-48would be performed as follows. The fusion cage 60 is attached to thehollow tube 2 by way of the above-discussed interference fit at fusioncage collar 92 and interior surface of distal end of hollow tube 2.Funnel 30 is then attached to upper portion of hollow tube at first orupper or proximal end of hollow tube 2 via knobs 6A. Bone graft or othersuitable substance as known to one skilled in the art is inserted atupper or first end 6 of hollow tube 2. Plunger 12 is then inserted intohollow tube 2 at upper or proximal end of hollow tube and pushed oradvanced axially down interior of hollow tube, thereby urging or pushingor advancing the bone graft material down the hollow tube 2 towardfusion cage 60. Bone graft then proceeds into the fusion cage 60 wherebyit at least substantially fills fusion cage 60 interior and furtherengages fusion cage internal ramps 72 and emits bone graft materialthrough fusion cage first opening pair 65 and fusion cage second openingpair 67 and thus enters surgical area (e.g. a spinal surgical area).Upon sufficient user (i.e. surgeon) selectable injection of bone graftmaterial into surgical site and fusion cage 60, the plunger 12 isretracted and removed from the hollow tube 2 by opposite axial movement,i.e. by moving the plunger 12 away from the fusion cage 60. The funnel30 may then be optionally removed. Next, the ejection tool 140 isinserted into hollow tube 2 at upper or proximal end Ejection tool 140is advanced until ejection tool second end 152 engages fusion cagecollar face 93, whereupon downward force is applied to push fusion cage60 from engagement with hollow tube 2. As discussed, ejection toolsecond end 152 is configured such that it may not travel past or intothe fusion cage. When sufficient axial force is applied to the ejectiontool 140 in the direction of the fusion cage 60, the interference fitthat secures the fusion cage 60 (at fusion cage collar 92) to hollowtube 2 (at second end 8 of hollow tube) is overcome and the fusion cage60 is released or disengaged from the hollow tube 2. The engagement tool140, and the hollow tube 2 in which it is inserted, are then removedfrom the surgical site, leaving a fusion cage at least substantiallyfilled with bone graft and a surgical site also at least substantiallyfilled with bone graft.

In one embodiment, all or a portion of fusion cage collar 92 is of amaterial different than the remainder of the fusion cage 60, e.g.comprising a metal alloy. In one embodiment, a portion of the distal endof the hollow tube 2 is of a material different than the remainder ofthe hollow tube 2, e.g. comprising a metal alloy. In one embodiment, aportion of the distal end of the ejection tool is comprised of a metalalloy.

In one embodiment of the device, the tip of the hollow tube and/orfusion cage may separate under a threshold pressure as applied axiallyfrom the inside of the hollow tube or fusion cage respectively. Such auser-selected threshold would allow bone graft material to enter thesurgical site if bone graft material becomes clogged in the hollow tubeand/or fusion cage.

Referring now to FIGS. 49-62, various embodiments and components of afusion cage 60 with expandable fusion cage feature are depicted.Generally, the fusion cage 60 comprises an upper plate 200, lower plate210, front block 220, rear block 230, and expansion screw 240. Byrotating the expansion screw 240, each of the front block 220 and rearblock 230 advance toward the center of the fusion cage 60 whilesimultaneously advancing each of the lower plate 210 and upper plate 220away from the center of the fusion cage 60, thereby expanding theoverall height of the fusion cage 60. Each of the unexpanded state ofthe fusion cage 60 and expanded state of the fusion cage 60 areunderstood most immediately by comparing FIGS. 49A and 50A,respectively. The fusion cage 60 may be expanded in a scalable manner toa maximum threshold height value. At the maximum threshold height valueof the fusion cage 60, each of the front block 220 and rear block 230are unable to continue to advance toward the center of the fusion cage60 (such a state is shown as FIG. 50A). It is noted that in theembodiments of FIGS. 49-60, the lower plate 210 and upper plate 220remain substantially parallel in all configurations. Stated another way,the lower plate 210 and upper plate 220 remain substantially parallel inthe unexpanded fusion cage 60 state (e.g. FIG. 49A), in the maximumthreshold height value expanded state of the fusion cage 60 (e.g. FIG.50A), and in all states in between. In contrast, in the fusion cage 60embodiment of FIGS. 61A-B, the lower plate 210 and upper plate 220maintain a relative vertical wedge angle, and in the embodiment of FIGS.62A-B, the lower plate 210 and upper plate 220 maintain a relativehorizontal wedge angle.

Expansion screw 240 comprises expansion screw head 242, expansion screwtip 244 and expansion screw disk 246. The expansion screw 240rotationally engages each of the front block 220 via front blockaperture 227 and rear block 230 via rear block aperture 237. Theexpansion screw disk 246 engages each of the upper plate 200 via upperplate slot 206 and the lower plate 210 via lower plate slot 216. Theexpansion screw 240 is configured with opposing screw threads on eachside of expansion screw disk 246. Each of the front block aperture 227and rear block aperture 237 are tapped to accept the expansion screw 240threads. As such, as the expansion screw 240 is rotated, each of theopposing screw threads engage each of the front block aperture 227 andrear block aperture 237 and advance the respective front block 220 andrear block 230 toward the center of the fusion cage 60. As provided inFIGS. 57A-C, expansion screw 240 comprises left hand threads on a firstportion of expansion screw 240 proximal to the expansion screw head 242and right hand threads on a second portion of expansion screw 240 distalto the expansion screw head 242. Thus, the left hand threads engage therear block aperture 237 and the right hand threads engage the frontblock aperture 227. The left hand and right hand threads are symmetricalalthough in opposite directions such that rotation of the expansionscrew 240 results in equal movement of each of the front block 220 andrear block 230. Stated another way, the operation of the expansion screw240 with respect to the front block 220 and rear block 230 is such thateach block advances toward (or retreats from) the center of the fusioncage 60 in equal amounts or distance with rotation of the expansionscrew 240.

In an alternate embodiment, the thread configurations (and respectivetapped apertures) are reversed. The expansion screw head 242 is fittedwith a star terminus so as to engage a star (a.k.a. Torx™) screwdriver.In other embodiments, the expansion screw head 242 is fitted with a starscrewhead (i.e. female, i.e. receptor, end) so as to engage a starscrewdriver (i.e. a male screwdriver.) In other embodiments, any meansof screw drive known to those skilled in the art may be employed, toinclude slot or regular, phillips, pozidriv, square, Robertson, hex, hexsocket, tri-wing, spanner head, clutch, double-square, triple-square,polydrive, spline drive, double hex, Bristol and pentalobular.

Front block 220 comprises front block upper rail 222, front block lowerrail 224, front block nose 225, front block ramp 226 and front blockaperture 227. As described above, front block aperture 227 is tapped toengage the threads of expansion screw 240. Each of front block upperrail 222 and front block lower rail 224 engage, respectively, upperplate track 205 and lower plate track 215. Such a configuration orarrangement may be referred to as a dovetail joint slider. As theexpansion screw is rotated, front block upper rail 222 moves or slideswithin upper plate track 205 toward the center of fusion cage and frontblock lower rail 224 moves or slides within lower plate track 215 towardthe fusion cage. Because of the wedged-shaped geometry of each of thefront block 220 and rear block 230, such movement toward the center ofthe fusion cage 60 results in an expansion (in height) of the fusioncage 60. Such movement also causes a reduction in the length of thefusion cage 60, in that the front block nose 225 retreats to theinterior of the fusion cage 60, thereby leaving the upper plate front201 and lower plate front 211, or the expansion screw tip 244, to definethe most distal end of the fusion cage 60. Such a change in fusion cage60 length is apparent by comparing, for example, FIGS. 49A and 50A. Inone embodiment, the expansion screw tip 244 is configured such that,when the fusion cage 60 is in a maximum expansion state, the expansionscrew tip 244 does not extend beyond a plane between the most distal endof the upper plate front 210 and lower plate front 211. It is noted thatin all states of expansion of the fusion cage 60, no aperture is formedat the nose of the fusion cage 60, e.g. between the front block 220 andeach of the upper plate 200 and lower plate 210. Stated another way, inall states of expansion of the fusion cage 60, to span unextended state(e.g. FIG. 49a ) and maximum extended state (e.g. FIG. 50A), no path foregress of material (e.g. bone graft) is provided from the interior ofthe fusion cage 60 through the front or nose area (i.e. in alongitudinal direction.) In an alternate embodiment, the front block 220is configured with one or more apertures, e.g. on one or more of frontblock ramp 236, so as to allow a path for said egress.

Front block 220 is symmetrical about a vertical plane (i.e. a planerunning parallel to each of front block upper rail 222 edge and frontblock lower rail 224 edge longitudinal axes and bisecting front blockaperture 227 at 12 and 6 o'clock positions.) Front block is symmetricalabout a horizontal plane (i.e. a plane running parallel to each of frontblock upper rail 222 surface and front block lower rail 224 surface andbisecting front block aperture 227 at 3 and 9 o'clock positions.)

Rear block 230 comprises rear block groove 231, rear block upper rail232, rear block lower rail 234, rear block ramp 236, rear block aperture237, rear block aft 238 and rear block detent 239. As described above,rear block aperture 237 is tapped to engage the threads of expansionscrew 240. Each of rear block upper rail 232 and rear block lower rail234 engage, respectively, upper plate track 205 and lower plate track215. As the expansion screw is rotated, rear block upper rail 232 movesor slides within upper plate track 205 toward the center of fusion cageand rear block lower rail 234 moves or slides within lower plate track215 toward the fusion cage. Because of the wedged-shaped geometry ofeach of the rear block 230 and rear block 230, such movement toward thecenter of the fusion cage 60 results in an expansion (in height) of thefusion cage 60. The rear block aft 238 is configured such that when thefusion cage 60 is in an unexpended state (e.g. FIG. 49A), the rear blockaft 238 is flush with the edges of each of upper plate rear 202 andlower plate rear 212. In one embodiment, the expansion screw head 242 isconfigured such that, when the fusion cage 60 is in an unexpanded state,the expansion screw head 242 is flush with the edges of each of upperplate rear 202, lower plate rear 212 and rear block aft 238.

Rear block 230 is similarly symmetrical about the same relative axes asfront block 220. That is, rear block 230 is symmetrical about a verticalplane (i.e. a plane running parallel to each of rear block upper rail232 edge and rear block lower rail 234 edge longitudinal axes andbisecting rear block aperture 237 at 12 and 6 o'clock positions.) Rearblock is symmetrical about a horizontal plane (i.e. a plane runningparallel to each of rear block upper rail 232 surface and rear blocklower rail 234 surface and bisecting front block aperture 237 at 3 and 9o'clock positions.)

Upper plate 200 comprises upper plate front 201, upper plate rear 202,upper plate opening 203, upper plate surface texture 204, upper platetrack 205, upper plate slot 206, upper plate ridge 209 and plate tab217. Upper plate surface texture 204 is formed of consecutive ridges ina lateral orientation, i.e. left-right rather than fore-aft. Inalternate embodiments, the upper plate surface texture 204 is formed ina longitudinal direction, i.e. fore-aft rather than left-right. In otheralternate embodiments, the upper plate surface texture 204 is of otherconfigurations known to those skilled in the art, to comprise groovesand ridges. Upper plate opening 203 comprises a pair of oval race-trackopenings. In other embodiments, upper plate opening 203 is a singleopening, is of circular shape, is of rectangular shape, or other shapesknown to those skilled in the art and/or conventionally used in fusioncages. Upper plate 200 is symmetric about a vertical plane runninglongitudinally between the two upper plate openings 203 and the upperplate track 205.

Lower plate 210 comprises lower plate front 211, lower plate rear 212,lower plate opening 213, lower plate surface texture 214, lower platetrack 215, lower plate slot 216, lower plate ridge 219 and plate tab217. Lower plate surface texture 214 is formed of consecutive ridges ina lateral orientation, i.e. left-right rather than fore-aft. Inalternate embodiments, the lower plate surface texture 214 is formed ina longitudinal direction, i.e. fore-aft rather than left-right. In otheralternate embodiments, the lower plate surface texture 214 is of otherconfigurations known to those skilled in the art, to comprise groovesand ridges. Lower plate opening 213 comprises a pair of oval race-trackopenings. In other embodiments, lower plate opening 213 is a singleopening, is of circular shape, is of rectangular shape, or other shapesknown to those skilled in the art and/or conventionally used in fusioncages. Lower plate 210 is symmetric about a vertical plane runninglongitudinally between the two lower plate openings 213 and the lowerplate track 215.

When the fusion cage 60 is in the unexpanded state (e.g. FIG. 49A),upper plate ridge 209 and lower plate ridge 219 are in communication,i.e. are touching or substantially touching.

Upper plate 200 and lower plate 210 are identical, and are assembled toform the fusion cage 60 by positioning in opposite orientations. Statedanother way, upper plate 200 and lower plate 210 are positioned tomirror one another about a horizontal plane through the center andmiddle height of the fusion cage 60. Among other things, identical upperplate 200 and lower plate 210 allow fewer unique parts to be used toassemble the fusion cage 60, thereby reducing costs, reducingcomplexity, and increasing robustness. Also, the fusion cage 60 designis such that the fusion cage remains structural stable and strong whileexpanded, to include when in the maximum expanded state, as enabled bythe type and degree of connections between the wedged blocks and theplates. That is, as enabled by the rail/track connections between theblocks and the plates, and also the adjacent surface connections of thewedged blocks (i.e. the area adjacent the rails of each block) and theplates.

The fusion cage 60 is a modular system in that components may becombined to cover several sizes and configurations. Although each of theupper plate 200 and lower plate 210 are identical, these paired platesmay be provided in several sizes. For example, as provided in FIGS.54A-F, a set of paired (i.e. one upper plate 200 and one lower plate210) plates may be provided in lengths of 26 mm, 32 mm and 36 mm. Also,the paired wedged blocks (i.e. a front block 220 and a rear block 230)may be provided in assorted sizes, e.g. an 8 mm and an 11 mm size, asdepicted in FIGS. 55A-E. Lastly, the expansion screw 240 may be providedin various configurations, as provided in FIGS. 57A-C, to matchcombinations of paired plates and paired wedged blocks. In oneembodiment, the fusion cage 60 may be constructed to range in size from8×26 mm to 14×36 mm.

In one embodiment, the expansion screw 240 comprises stainless steel andtitanium, and the upper plate 200 and lower plate 210 comprise stainlesssteel, titanium and polyether ether ketone (PEEK.)

Additional components that are configured to engage the fusion cage 60are provided in FIGS. 63-72. Generally, the additional componentscomprise those that allow the fusion cage 60 to be positioned at orwithin a surgical site, to expand and/or contract the fusion cage 60,deliver bone graft material within the fusion cage 60 and to thesurrounding surgical site, and detach the fusion cage.

With attention to FIGS. 63-69, a fusion cage 60 with expandable fusioncage feature, as described above, is depicted with an installer/impactor250 component. The installer/impactor 250 comprises installer/impactortip 252, installer/impactor aperture 253, installer/impactor ridge 254,installer/impactor channel 255, installer/impactor ramp 256 andinstaller/impactor handle 258. The installer/impactor aperture 253 isconfigured to engage the rear block aperture 253 and theinstaller/impactor ridges 254 are configured to engage the rear blockdetent 239; once these elements are engaged, the fusion cage 60 may beaccurately and reliable positioned at the surgical site. Theinstaller/impactor handle 258, with integrated striking plate, may beused to assist in guiding the fusion cage 60 into place, and furtherallows a “persuading” with a mallet. The installer/impactor handle 258attaches in place with, for example, a ball detent or similar featurethat secures the installer/impactor handle 250 in place yet allows quickand easy removal.

FIG. 65A details the installer/impactor 250 engaged with the fusion cage60, the fusion cage 60 in an unexpanded state. FIG. 65B details the samesystem and configuration of FIG. 65A, except that the expansion driver260, with expansion driver handle 268, is engaged with the fusion cage60. More specifically, the expansion driver 260, which fits within theinstaller/impactor 250, engages the expansion screw head 242 (e.g. theexpansion screw head 242 is a male star or Torx™ screw head that engageswith the female star or Torx™ screwdriver end of the expansion driver260.) FIG. 66 details the installer/impactor 250 engaged with the fusioncage 60, the fusion cage 60 in an expanded state (as a result of theexpansion driver 260 engaging the expansion screw head 242 and, throughrotation of the expansion screw head 242, expanding the fusion cage 60),and the hollow tube 2 fitted over the installer/impactor 250.

After the fusion cage 60 is expanded to the desired degree, i.e. height,the expansion driver 260 disengages from the expansion screw head 242and is removed. The hollow tube 2 is then slid downward or distally soas to engage the fusion cage 60, and the installer/impactor 250 must beremoved (so as to allow bone graft material to be delivered via hollowtube 2 into the fusion cage 60 and the surrounding surgical site.) FIG.67 details the installer/impactor 250 engaged with the fusion cage 60,the fusion cage 60 in an expanded state, and the hollow tube 2 fittedover the installer/impactor 250 and engaged with the fusion cage 60;this is the configuration of the an integrated expandable fusion cageand bone graft delivery device when the installer/impactor 250 must beremoved so as to enable bone graft delivery. In an alternate embodiment,the installer/impactor 250 is not used, and instead the hollow tube 2 isused to position the fusion cage 60 by way of the hollow tube externalramp 280 and/or hollow tube notch 282. The hollow tube external ramp 280may form a press-fit with the fusion cage 60. The hollow tube may alsoengage the fusion cage 60 via the hollow tube notch 282, the hollow tubenotch 282 configured to engage the rear block aft 238 portion above andbelow the rear block aperture 237.

FIGS. 68A-B detail a means with which the installer/impactor 250 may beremoved by use of removal pliers 270. The removal pliers 270 areconfigured to engage the first end 6 of hollow tube and the proximal endof the installer/impactor 250, so as to pull the installer/impactor 250from engagement with the fusion cage 60. Note that theinstaller/impactor 250 is configured to allow the installer/impactor tip252 to spread apart over the rear block detent 239 groove, asfacilitated by the installer/impactor channel 255.

After the fusion cage 60 has been positioned in the surgical site andexpanded as required, bone graft material may be inserted into thefusion cage 60 and into the surrounding surgical site. FIG. 69 presentsan exploded perspective view of the fusion cage 60 with expandablefusion cage feature engaged with the hollow tube 2 component and funnel30 component, as configured to engage with the plunger 12 component. Asdescribed previously, bone graft material is placed into the funnel 30and advanced down the hollow tube 2 by the plunger 12, whereby bonegraft material flows into the fusion cage 60 and outward into thesurgical site via one or more of the upper plate openings 203, lowerplate openings 213, and lateral openings distal to the front block 230.

FIGS. 70-72 depict an alternate embodiment of hollow tube 2 and fusioncage 60 to enable the fusion cage 60 to be accurately and reliablypositioned at a surgical site. The hollow tube 2 comprises two pairs ofhollow tube slots 284, each with a hollow tube slot aperture 285 at thedistal end. Each hollow tube slot 284 is disposed at least partially onthe hollow tube external ramp 280. Each of the upper plate 200 and lowerplate 210 comprise a pair of plate tabs 217, each of which engages oneof the hollow tube slot apertures 285. When such an engagement occurs,the fusion cage 60 is slightly expanded as the hollow tube 2 is insertedinto the fusion cage 60. In this arrangement, as the fusion cage 60 isexpanded, the plate tabs 217 retreat or release from the hollow tubeslot apertures 285; however, the hollow tube 2 still engages orregisters with the fusion cage 60 via the hollow tube notches 282 whichremain engaged with the rear block aft 238.

In one embodiment, the expansion screw 240 is configured to lock atdefined expansion states of the fusion cage 60, to include at a maximumexpansion state (as defined, e.g. as the maximum height dimension ofwhich the fusion cage 60 may expand.)

In another embodiment, the fusion cage 60 with expandable cage featureis configured of modified and integrated embodiments of theafore-mentioned components. For example, FIG. 73 depicts a fusion cage60 with expandable fusion cage feature wherein the upper plate 200 andlower plate 210 are joined through a plate nose element 218 (“plate/noseelement”). These combined components are configured to form a firststate wherein a minimal vertical height is provided and/or a flatprofile is presented. Horizontal notches fitted between the upper plate200 and plate nose element 218, and between the lower plate element 210and plate nose element 218, enable the integrated upper plate 200, lowerplate 210 and plate nose element to expand upon engagement with anintegrated front block 220 and rear block 230 element. The integratedfront block 220 and rear block 230 element comprises a block spine 228(“block/spine element”) such that, when inserted into theafore-mentioned plate/nose element, the fusion cage 60 expands. In oneembodiment, each of the afore-mentioned integrated components would beheld in a pistol grip type insertion tool (as known to those skilled inthe art) which would allow placement of the unexpanded (i.e. thecollapsed) plate/nose element into the surgical site (e.g. a disk space)with the block/spine element staged right behind. Upon pulling a leveron the pistol grip tool, the plate/nose element would be inserted intothe block/spine element (in one embodiment, this insertion isfacilitated by upper plate track 205 and lower plate track 215 engagingrespective upper and lower rails of the block/spine element), therebyexpanding the plate/nose element and forming an expanded fusion cage 60.In one embodiment, a locking feature is provided such that theplate/nose and block/spine elements are secured or locked together. Inone embodiment, the insertion of this fusion cage 60 embodiment is byway of hollow tube 2 (e.g. the embodiment described in FIGS. 70-72). Inone embodiment of the fusion cage 60 as provided in FIG. 73, one or moreupper plate openings 203 and/or one or more lower plate openings 213 areprovided.

In one embodiment, no springs, such as wire springs, are employed toexpand the fusion cage 60. In one embodiment, other means, as known tothose skilled in the art, are used to expand the fusion cage 60, toinclude springs, gears, cams, magnetic, electrical, electro-mechanical,electro-magnetic, and optical.

The means and components disclosed may engage, integrate and/orcommunicate with the fusion cage 60 embodiments of the disclosure aswell as with traditional and conventional fusion cages. That is, thecomponents of the disclosure may be readily adapted to engageconventional fusion cages, including expandable fusion cages, of theprior art. More specifically, the hollow tube 2, installer/impactor 250,expansion driver 260, and/or plunger 12 may be adapted to engage fusioncages of the prior art. FIG. 74 provides a representative depiction ofadaptations of components of the disclosure so as to engage conventionalfusion cages, both fixed or static fusion cages and expandable fusioncages.

In one embodiment, the bone graft delivery system of the disclosure mayengage with an expandable fusion cage of the prior art. For example, thehollow tube 2 may be configured to engage the prior art (expandable)fusion cage 400 shown by, for example, geometric sizing of the hollowtube first distal opening 8, and/or fitting the hollow tube first distalopening 8 with a malleable portion that may be compressed and/orexpanded so as to engage the prior art (expandable) fusion cage 400,and/or fitting to a adaptor 300 portion. Additionally, theinstaller/impactor 250 may be adapted (e.g. to use the sameconfiguration of expansion end as that of the depicted fusion cage) tocommunicate with the end portion of the prior art (expandable) fusioncage 400 so as to enable the expansion of the prior art (expandable)fusion cage 400. The prior art (expandable) fusion cage 400 may also beengaged with one or more components of the disclosure, e.g. the hollowtube 2 and/or installer/impactor 250.

In one embodiment of the fusion cage 60, the fusion cage of the priorart is adapted wherein one or more of the upper plate 200 and/or lowerplate 210 is adapted to fit on paired opposite sides of the fusion cage.

In another embodiment, the bone graft delivery system of the disclosuremay engage with an unexpandable fusion cage of the prior art. The hollowtube 2 is configured to engage the prior art (unexpandable) fusion cage400 shown by, for example, geometric sizing of the hollow tube firstdistal opening 8, and/or fitting the hollow tube first distal opening 8with a malleable portion that may be compressed and/or expanded so as toengage the prior art (expandable) fusion cage 400, and/or fitting to anadaptor portion 300.

FIG. 74 depicts the bone graft delivery system of the disclosure, asengaged with an unexpandable fusion cage of the prior art, specificallyan unexpandable fusion cage provided in US2012/0065613 and/orhttp://thompsonmis.com/node/23, incorporated by reference in entirety.The hollow tube 2 is configured to engage the prior art (unexpandable)fusion cage 400 shown by, for example, geometric sizing of the hollowtube first distal opening 8, and/or fitting the hollow tube first distalopening 8 with a malleable portion that may be compressed and/orexpanded so as to engage the prior art (expandable) fusion cage 400,and/or fitting to an adaptor portion 300 (as shown).

In one embodiment, the adaptor 300 comprises at least two forked tinesto engage, for example, exterior surfaces of a fusion cage. In oneembodiment, the adaptor 300 forms an angled tool, that is, the adaptor300 and the hollow tube 2 are not aligned or linear. In anotherembodiment, the adaptor 300 forms an angled tool relative to a fusioncage when engaged with a fusion cage, that is, the adaptor 300 and thehollow tube 2 are aligned or linear but are not in alignment with anengaged fusion cage.

In one embodiment, the fusion cage 60 is actuated, eg the expansionscrew 240 is operated, remotely, e.g. through electrical means, magneticmeans or other means known to those skilled in the art, during surgeryor post-operative. The later situation, i.e. post-operative, enablesadjustment of the height of the fusion cage 60 after surgery. In oneembodiment, the fusion cage e.g. the expansion screw is operated ormanipulated by way of additional devices to comprise a servo-motor.

In one embodiment, the fusion cage 60 is used in applications comprisingL-LIF, A-LIF, Corpectomy adaptation, deformity correction and increasinglordosis.

In one embodiment, the expansion screw 240, comprising a left hand and aright hand threaded screw portion and a central disk, engages twoopposing blocks at a 30 degree ramp angle with a dovetail joint. As theblocks are drawn in, the cage plates are forced outward (in the verticaldirection). The narrow disk at the center of the screw registers in theslots of the cage plates to keep the plates from shifting fore/aft,reducing if not eliminating binding of the mechanism.

In one embodiment, at least some of the fusion cage is manufacturedusing 3-D printing technologies, metal additive manufacturing (AM),subtractive machining and/or direct metal laser sintering (DMLS) and maybe provided a porous coating. In one embodiment, the fusion cage 60comprises one or more surfaces, especially exterior surfaces, with poresso as to, for example, promote osseointegration. The article “EOS Teamswith Medical Implant Designer to Advance 3D Printing in Medicine”published Oct. 17, 2012 in Graphic Speak is incorporated by reference inentirety.

In one configuration, the fusion cage comprises a titanium alloy, suchas Ti6AL4V and/or lattice structures, the lattice structures coveringall or at least part of one or more apertures of the fusion cage 60. Inone configuration, the lattice structures in FIG. 82, hereinincorporated by reference in entirety.

In one configuration, the hollow tube 2 is configured such that itsdistal upper and lower interior surfaces have grooves to engage theupper and lower portions of the rear cage actuating wedge. The screwtool, fitting inside the cannula, is still used to expand the cage. Onceexpanded, the screw tool is removed. Then BG material is inserted usingthe cannula/plunger scheme. The screw tool is put back in to engage theexpandable screw and hold the fusion cage in place. The modified(interior grooved) cannula is pulled away from the cage with the screwtool providing an opposing force to the cage. The screw tool is thenremoved. Furthermore, the distal end of the modified cannula may be madeof an elastic material so that, if initially engaged with the cage incompression, it expands as the cage expands to provide a sealed fit withthe cage as the cage expands, thereby allowing a clean flow of BGmaterial into the cage i.e. no back-flow.

In one embodiment, one or more alignment markers are placed on thefunnel, e.g. lines at 0 degree and 180 degree. In one embodiment, one ormore clamps are applied to the hollow tube for additional support and/orstability. The clamps may be, e.g. scissor-type clamps. In oneembodiment, all or a portion of the plunger, hollow tube, fusion cageand ejection tool comprise a thermoplastic polycarbonate such as Lexan™.In one embodiment, the fusion cage comprises a different material thanone or more of the hollow tube, plunger and ejection device. In oneembodiment, the plunger comprises an elastic portion and elastic sealwhich functions, among other things, to restrict wiggle of the plungerwhen moving through the hollow tube. In one embodiment, one or moreportions of the device are manufactured via sonic welding, and/orcomprise a sonic weld. For example, the tip of the hollow tube and/orfusion cage may be sonic welded or comprise a sonic weld.

In one embodiment of the device, the width of the hollow tube secondexterior surface 5 is between 10 and 14 mm. In a preferred embodiment,the width of the hollow tube second exterior surface 5 is between 11 and13 mm. In a most preferred embodiment, the width of the hollow tubesecond exterior surface 5 is between 11.5 mm and 12.5 mm. In a preferredembodiment, the width of the hollow tube second exterior surface 5 is 12mm.

In one embodiment of the device, the width of the hollow tube firstexterior surface 3 is between 6 and 10 mm. In a preferred embodiment,the width of the hollow tube first exterior surface 3 is between 7 and 9mm. In a most preferred embodiment, the width of the hollow tube firstexterior surface 3 is between 7.5 mm and 8.5 mm. In a preferredembodiment, the width of the hollow tube first exterior surface 3 is 8mm.

In one embodiment of the device, the ratio of the width of the hollowtube second exterior surface 5 and the width of the hollow tube firstexterior surface 3 is between 1.7 and 1.3. In a preferred embodiment,the ratio of the width of the hollow tube second exterior surface 5 andthe width of the hollow tube first exterior surface 3 is between 1.6 and1.4. In a most preferred embodiment, the ratio of the width of thehollow tube second exterior surface 5 and the width of the hollow tubefirst exterior surface 3 is between 1.55 and 1.45. In one embodiment,the ratio of the width of the hollow tube second exterior surface 5 andthe width of the hollow tube first exterior surface 3 is 1.5.

In one embodiment of the device, the width of the interior of the hollowtube major axis (located adjacent the second exterior surface 5) isbetween 9 and 13 mm. In a preferred embodiment, the width of theinterior of the hollow tube major axis is between 10 and 12 mm. In amost preferred embodiment, the width of the interior of the hollow tubemajor axis is between 10.5 mm and 11.5 mm. In a preferred embodiment,the width of the interior of the hollow tube major axis is 11 mm.

In one embodiment of the device, the width of the interior of the hollowtube minor axis (located adjacent the first exterior surface 3) isbetween 5 and 9 mm. In a preferred embodiment, the width of the interiorof the hollow tube minor axis is between 6 and 8 mm. In a most preferredembodiment, the width of the interior of the hollow tube minor axis isbetween 6.5 mm and 7.5 mm. In a preferred embodiment, the width of theinterior of the hollow tube minor axis is 7 mm.

In one embodiment of the device, the ratio of the width of the interiorof the hollow tube major axis and the width of the interior of thehollow tube minor axis is between 1.7 and 1.3. In a preferredembodiment, the ratio of the width of the interior of the hollow tubemajor axis and the width of the interior of the hollow tube minor axisis between 1.6 and 1.4. In a most preferred embodiment, the ratio of thewidth of the interior of the hollow tube major axis and the width of theinterior of the hollow tube minor axis is between 1.55 and 1.45. In oneembodiment, the ratio of the width of the interior of the hollow tubemajor axis and the width of the interior of the hollow tube minor axisis 1.5.

It should be noted that the rectangular configuration of the hollow tubeaffords several advantages over conventional circular configuration. Forexample, for a surgical area with smallest dimension set at a width of 8mm with thickness dimension 0.5 mm, a conventional circular device (withresulting interior diameter of 7 mm or a radius of 3.5 mm) would realizea surface area of 38.48 mm.sup.2. Applicants' device would carryinterior dimension of 7 mm by 11 mm for a surface area of 77 mm, anincreased surface area factor of 2.0, thereby resulting in more bonegraft material delivery, because, among other things, a given volume ofbone graft encounters less surface area of the interior of a particulardevice which results in, among other things, reduced chance of jammingof bone graft material within the device.

In one embodiment, a one or more edges of the device are rounded. Forexample, the exterior edges of the hollow tube are rounded, and/or theinterior edges of the hollow tube are rounded (in which case the edgesof the plunger, at least at the plunger distal end, are identicallyrounded to ensure a congruous or conformal fit between the edges of theplunger and the interior of the hollow tube so as to, among otherthings, urge the majority of bone graft material to move through thehollow tube).

In one embodiment, the handle 16 of plunger is a planar disk shape, asdepicted in FIG. 23. In another embodiment, handle 16 is not planar. Forexample, handle 16 is angled so as to conform to interior of funnel 30when the plunger 12 is fully inserted into hollow tube 2.

In one embodiment, the hollow tube distal interior ramp surfaces 9A arelinear in shape, that is, forming a triangle in cross-section. Inanother configuration, the hollow tube distal interior ramp surfaces 9Aare of any shape that urges egress of bone graft material contained inthe hollow tube to exit the interior of the hollow tube through the pairof first distal openings 7 of the device 1.

A bone graft tamping device may also be provided, which is adapted to betelescopically inserted into the hollow tube after the plunger isremoved from the hollow tube. The bone graft tamping device, accordingto this embodiment, may include one or more longitudinal channels alongthe outer circumference of the bone graft packer for permitting anytrapped air to flow from the bone graft receiving area to the graspableend of the hollow tube during packing of bone graft. The bone graftpacker may further include a handle at one end designed ergonomicallyfor improving ease of use. The bone graft packer in this embodimentthereby facilitates packing of bone graft within the hollow tube.

The hollow tube may also be fitted with a passageway wherein a surgicaltube or other device may be inserted, such as to deliver a liquid to thesurgical area or to extract liquid from the surgical area. In such anembodiment, the plunger is adapted in cross-section to conform to thehollow tube's cross-section.

In another embodiment of the present invention, a kit of surgicalinstruments comprises a plurality of differently sized and/or shapedhollow tubes and a plurality of differently sized and/or shapedplungers. Each of the plungers correspond to at least one of the hollowtubes, whereby a surgeon may select a hollow tube and a plunger whichcorrespond with one another depending upon the size and shape of thegraft receiving area and the amount or type of bone graft to beimplanted at such area. The corresponding hollow tubes and plungers areconstructed and arranged such that bone graft can be placed within thehollow tubes with the plungers, and inserted nearly completely into thehollow tubes for removing substantially all of the bone graft materialfrom the hollow tubes, such as in the preferred embodiments for theplunger described above. The use of more than one hollow tube/plungercombination permits at least two different columns of material to beselectably delivered to the targeted site, e.g. one of bone graftmaterial from the patient and another of Bone Morphogenetic Protein(BMP), or e.g. two different types of bone graft material or onedelivering sealant or liquid. Also, one or both hollow tubes could bepreloaded with bone graft material.

The kit of surgical instruments may comprise a plurality of differentlysized and/or shaped graft retaining structures, each corresponding to atleast one hollow tube and at least one plunger.

The bone graft receiving area can be any area of a patient that requiresdelivery of bone graft. In the preferred embodiment, the bone graft isdelivered in a partially formed manner, and in accordance with anotheraspect of the present invention, requires further formation afterinitial delivery of the bone graft.

Another embodiment of the present invention provides a method by which ahollow tube and a plunger associated with the hollow tube are providedto facilitate delivery of the bone graft to a bone graft receiving area.

According to one embodiment, the present invention provides a bone graftdelivery system, by which a hollow tube and/or plunger assembly may beprepared prior to opening a patient, thus minimizing the overall impactof the grafting aspect of a surgical implantation or other procedure.Moreover, the hollow tube may be made to be stored with bone graft in itfor a period of time, whether the tube is made of plastic, metal or anyother material. Depending upon the surgical application, it may bedesirable to only partially fill the tube for storage, so that a plungercan be at least partially inserted at the time of a surgery.

Thus, the integrated fusion cage and graft delivery device may eithercome with a pre-filled hollow tube, or a non-filled hollow tube, inwhich the surgeon will insert bone graft received from the patient(autograft), or from another source (allograft). In either case, thesurgeon may first remove any wrapping or seals about the hollow tube,and/or the pre-filled bone graft, and insert the hollow tube into thepatient such that the second end of the hollow tube is adjacent the bonegraft receiving area. Once the hollow tube is in place, and the openingat the second end of the hollow tube is oriented in the direction of thedesired placement of bone graft, the surgeon may then insert the secondend of the plunger into the opening at the first end of the hollow tube,and begin pressing the second end of the plunger against the bone graftmaterial in the hollow tube. In this fashion, the plunger and hollowtube cooperate similar to that of a syringe, allowing the surgeon tosteadily and controllably release or eject bone graft from the secondend of the hollow tube as the plunger is placed farther and farther intothe opening in the hollow tube. Once the desired amount of bone grafthas been ejected from the hollow tube (for in some instances all of thebone graft has been ejected from the hollow tube) the surgeon may removethe plunger from the hollow tube, and complete the surgery. In certainoperations, the surgeon may elect to place additional bone graft intothe hollow tube, and repeat the steps described above. Furthermore, thepre-filled bone graft elements may be color-coded to readily identifythe type of bone graft material contained therein.

According to the embodiment described in the preceding paragraph, thepresent invention may be carried out by a method in which access isprovided to a graft receiving area in a body, bone graft is placed intoa hollow tube having a first end and a second end, the hollow tube,together with the bone graft, is arranged so that the first end of thehollow tube is at least adjacent to the graft receiving area and permitslateral or nearly lateral (in relation to the longitudinal axis of thehollow tube and plunger assembly) introduction of bone graft to thegraft receiving area. This method prevents loss of bone graft due toimproper or limited orientation of the integrated fusion cage and graftdelivery device, and further allows a user to achieve insertion of adesired quantity of bone graft by way of the contoured plunger andhollow tube configuration described according to preferred embodimentsherein.

The method of the present invention may also be carried out by providinga hollow tube having a first end and a second end, constructed so thatit may receive a measurable quantity of bone graft, and so that thefirst end may be arranged at least adjacent to a bone graft receivingarea, and so that bone graft can be delivered from the first end of thehollow tube through the second end of the hollow tube and eventually tothe bone graft receiving area upon movement of the plunger in agenerally downward direction through the hollow tube (i.e., in adirection from the first end to the second end). According to thisembodiment, a graft retaining structure may also be provided for use inconnection with the contoured edge of the plunger, such that the graftretaining structure is positioned between the contoured edge of theplunger and the bone graft, but which is adhered to the bone graft andremains at the graft receiving area following removal from the hollowtube. In one embodiment, the bone graft is provided in discrete packagesor containers. Furthermore, this graft retaining structure may also beemployed with another tool, such as a graft packer, which is employedeither before or after the hollow tube is removed from the graftreceiving area.

In another embodiment, the one or more plungers corresponding to the oneor more hollow tubes are positioned with distal ends near the proximateend of the horizontal tube before use, said plungers having a detent toretain plunger in ready position without undesired movement beforesurgeon chooses which one or more plungers to extend through hollowhorizontal tube and deliver bone graft material and/or desired materialto the surgical area.

According to another embodiment of the present invention, a hollow tubeand plunger assembly is provided in which the hollow tube and/or theplunger assembly is disposable. Alternatively, the tube may be made of abiocompatible material which remains at least partially in the patientwithout impairing the final implantation. Thus, the hollow tube may beformed from a material that is resorbable, such as a resorbable polymer,and remain in the patient after implantation, so as not to interferewith the growth of the bone or stability of any bone graft or implant.

The current design preferably comprises a hollow tubular membercomprising a rounded edge rectangular shaft, which may be filled or ispre-filled with grafting material. The loading is carried out by theplunger. The rectangular design is preferable as it allows the largestsurface area device to be placed into the annulotomy site of a disk, butin other embodiments may be formed similar to conventional round shafts.The other preferred feature includes a laterally-mounted exit site forthe graft material. The combination of this design feature allowsdirection-oriented dispersion of the graft material. This allowsejection of the graft material into an empty disk space as opposed tobelow the hollow tube, which would tend to impact the material and notallow its spread through a disk space.

Another feature of this design is that a rectangular design allows theuser to readily determine the orientation of the device and thereby thedirection of entry of the bone graft material into the surgical area.However, such a feature may be obtained alternatively through exteriormarkings or grooves on the exterior on the hollow tube. Such exteriorgrooves or markings would allow use of a range of cross-sections for thedevice, to include a square, circle, or oval while allowing the user toreadily determine the orientation of the device relative to thedirection of entry of the bone graft material into the surgical area.

A further feature of this design is that an anti-perforation footing orshelf is paced on the bottom of the hollow tube to prevent annularpenetration and/or injury to the patient's abdomen or other anatomyadjacent the bone graft receiving area.

Another alternative embodiment to the design described herein includes aremovable funnel attachment. This allows easy loading of the cannulawith the funnel and with its removal easy visualization of the operatingsite without visual blockage through the microscope.

In another embodiment of the invention, all or some of the elements ofthe device or sections of all or some of the device may be disposable.Disposable medical devices are advantageous as they typically havereduced recurring and initial costs of manufacture.

In another embodiment of the device, the distal tip or end of theplunger device is composed of a different material to the rest of theplunger, so as the material at the distal end of the plunger issponge-like or softer-than or more malleable than the rest of theplunger so as upon engagement with the interior distal end of the hollowtube, the distal end of the plunger substantially conforms to theinterior configuration of the hollow tube. Similarly, the plunger distalend may be made of a material that is adaptable to substantially conformto the interior shape of the distal end of the hollow tube. Suchconfigurations enable substantially all of the material contained withinthe plunger to be delivered to the targeted site.

Another alternative embodiment to the design described herein includes anavigation aid on one or more surfaces of the tubular body to permitsurgeon to know how far the device has been inserted or to ensure properalignment relative to a transverse bone graft delivery site (i.e. discspace). Such capability is particularly important when the patient orsurgical area is not positioned immediately below the surgeon, ormultiple procedures are being performed. A navigation aid allows moreimmediate and reliable locating of the surgical area for receiving ofbone graft material. In one embodiment, the hollow tube is scored ormarked or provides some affirmative indication, actively or passively,to the surgeon to indicate degree of delivery of the material, e.g. bonegraft material, to the delivery site, and/or position of the plungerelement. For example, the exterior of the hollow tube could becolor-coded and/or provided with bars. In another embodiment, a computerand/or electro-mechanical sensor or device is used to provide feedbackto the surgeon to indicate degree of delivery of the material, e.g.amount of cc's of bone graft material, to the delivery site, and/orposition of the plunger element.

In another alternative embodiment to the design described herein, theplunger could include an activation device, which is often in a liquidor semi-liquid state, and that may be injected once the semi-solidportion of the morphogenic protein has been displaced by the movement ofthe plunger through the tubular body. That is, the plunger pushes thedry material, and once completed has a bulb or other device on theusable end to insert the liquid portion of the activating agent throughthe inner lumen within the plunger to evacuate the liquid from theplunger and out an opening at the non-usable end of the plunger so as tocontact the dry material already inserted into the disc space).

In one embodiment of the device, all or portions of the device aremanufactured using 3-D printing techniques. In another embodiment, allor portions of the device are made by injection molding techniques.

In one embodiment, the ratio of the surface area of the bottom tip ofthe plunger is approximately half the surface area of the two lateralopenings at the distal portion of the hollow tube.

In one embodiment, the device includes a supplemental means of grippingthe device, such as a laterally extending cylindrically-shaped handlethat engages the hollow tube.

In one embodiment, the material inserted into the hollow tube is anon-Newtonian fluid. In one embodiment, the device is adapted to acceptand deliver compressible fluids. In another embodiment, the device isadapted to accept and deliver non-compressible fluids.

In one embodiment, the upper portion of plunger is fitted with one ormore protrusions, which extends from the surface of the plunger so as toengage the upper surface of the hollow tube, to prevent the plunger fromengaging the distal interior portion of the hollow tube. In oneembodiment, the upper portion of plunger is fitted with one or moreprotrusions to prevent the plunger from engaging the apex of the hollowtube distal interior ramp surface.

In one embodiment, the funnel attaches to the upper portion of thehollow tube by a bayonet connection. In one embodiment, the funnelattaches to the upper portion of the hollow tube by an interference fit.In one embodiment, the funnel attaches to the upper portion of thehollow tube by a threaded connection. In one embodiment, the funnelattaches to the upper portion of the hollow tube by a slot/grooveconnection.

In one embodiment, the second end of hollow tube has one hollow tubedistal opening. In one embodiment, the second end of hollow tube has twohollow tube distal openings located on opposite sides. In oneembodiment, the second end of hollow tube has no more than two openings,the openings located on opposite sides.

In one embodiment, after bone graft material is delivered to a surgicalsite, a cavity approximately defined by the volume engaged by the devicewhen inserted into the surgical site is left in the surgical site uponremoval of the device from the surgical site. In one embodiment, theaforementioned cavity is then used as the site for insertion of a fusioncage.

The integrated fusion cage 60 with expandable cage feature provides anumber of unique and innovative features not provided by conventional ortraditional integrated fusion cages. For example, the integrated fusioncage with expandable cage feature of the disclosure is intentionally anddeliberately designed to receive bone graft material (or any materialsuitable for use in surgical applications, as known to those skilled inthe art) at its proximal end (ie the end generally facing the surgeonand/or the end opposite the end initially directed into a surgicalsite), such that the bone graft material flows into the fusion cage andalso flows out from the fusion cage into the surgical site. Suchfeatures as the interior ramps of the fusion cage (e.g. located withinthe interior of the hollow tube, and/or on the front and/or rear blocksof the fusion cage) function to direct received bone graft material intothe surgical site. Additionally, the features of the hollow tube andplunger wherein a greater volume of bone graft material may be reliably(e.g. not prone to blockage as is typical with most convention eg roundhollow tubes or cannula systems) and readily delivered to a surgicalsite and/or a fusion cage are unique and not found in the prior art.Among other things, such features encourage improved surgical results bydelivering more volume and coverage of bone graft material to thesurgical site. Also, such features minimize gaps in bone graft coverageto include gaps between the fusion cage area and the surroundingsurgical site. Also, the features of the one or more apertures of thefusion cage of the disclosure enable and encourage delivery of bonegraft material, as received by the fusion cage, into the surroundingsurgical site.

In contrast, conventional fusion cages, to include expandable fusioncages, do not provide such features and/or functions. For example, U.S.Pat. No. 8,852,242 to Morgenstern Lopez (“Lopez”), discloses a dilationintroducer for orthopedic surgery for insertion of an intervertebralexpandable fusion cage implant. The Lopez device does not allow receiptof bone graft material from its proximal end, or any end, in contrast tothe disclosed fusion cage and fusion cage/bone graft delivery system.That is, the Lopez proximal end includes an array of components, all ofwhich do not allow receipt of bone graft material. Furthermore, theLopez device requires an elaborate array of components, e.g. upper sideportion 240 of the upper body portion 202 and lower side portion 242 ofthe lower body portion 204, which also block any egress of bone graftfrom the inside of the Lopez fusion cage once deployed. Also, the Lopezwedges occupy the entire interior of the cage; there are no ramps todirect graft from the interior to the disk space. In short, the Lopezdesign is not made with bone graft delivery in mind, and indeed, cannotfunction to accept let alone deliver bone graft. Additionally,suggestions provided in the Lopez disclosure to deliver bone graft tothe surgical site would not provide the integrated and complete fusioncage and surgical site bone graft delivery of the invention, e.g. theLopez slot 918 of the Lopez lumen 916 and funnel assembly 910 at bestprovides limited delivery of bone graft material only before and afterinsertion of the Lopez fusion cage, and then only peripheral to thefusion cage. Also, it appears the Lopez device provides wedges 206 and208 of similar if not identical interior ramp angles. In contrast, incertain embodiments of the present invention the interior wedgedsurfaces of the invention, i.e. front block ramp 226 and rear block ramp236, are not of the same configuration and/or shape, e.g. front blockramp 226 is of a curved profile and rear block ramp 236 is of a linearor straight-line profile. Among other things, the curved profile of thefront block ramp 226 urges egress of bone graft as received by thefusion cage 60.

In one embodiment of the fusion cage 60, no anti-torque structures orcomponents are employed. In one embodiment of the invention, the lateralsides of the fusion cage 60 are substantially open to, among otherthings, allow egress of bone graft material as received to the fusioncage. In one embodiment, the expansion screw 240 is configured with alocking mechanism, such that the fusion cage 60 may be locked at a setexpansion state. In one embodiment, such a locking mechanism is providedthrough a toggle device operated at or on the installer/impactor handle258.

In one embodiment, the front block ramp 226 and rear block ramp 236 areidentical and/or symmetrical.

In addition, it is contemplated that some embodiments of the fusion cage60 can be configured to include side portions that project therefrom andfacilitate the alignment, interconnection, and stability of thecomponents of the fusion cage 60.

Furthermore, complementary structures can also include motion limitingportions that prevent expansion of the fusion cage beyond a certainheight. This feature can also tend to ensure that the fusion cage isstable and does not disassemble during use.

In some embodiments, the expansion screw 240 can facilitate expansion ofthe fusion cage 60 through rotation, longitudinal contract of a pin, orother mechanisms. The expansion screw 240 can also facilitate expansionthrough longitudinal contraction of an actuator shaft as proximal anddistal collars disposed on inner and outer sleeves move closer to eachother to in turn move the proximal and distal wedged block memberscloser together. It is contemplated that in other embodiments, at leasta portion of the actuator shaft can be axially fixed relative to one ofthe proximal and distal wedge block members with the actuator shaftbeing operative to move the other one of the proximal and distal wedgemembers via rotational movement or longitudinal contraction of the pin.

Further, in embodiments wherein the engagement screw 240 is threaded, itis contemplated that the actuator shaft can be configured to bring theproximal and distal wedged block members closer together at differentrates. In such embodiments, the fusion cage 60 could be expanded to aV-configuration or wedged shape. For example, the actuator shaft cancomprise a variable pitch thread that causes longitudinal advancement ofthe distal and proximal wedged block members at different rates. Theadvancement of one of the wedge members at a faster rate than the othercould cause one end of the implant to expand more rapidly and thereforehave a different height that the other end. Such a configuration can beadvantageous depending on the intervertebral geometry and circumstantialneeds.

In other embodiments, the implant 200 can be configured to includeanti-torque structures. The anti-torque structures can interact with atleast a portion of a deployment tool during deployment of the fusioncage 60 implant to ensure that the implant maintains its desiredorientation. For example, when the implant is being deployed and arotational force is exerted on the actuator shaft, the anti-torquestructures can be engaged by a non-rotating structure of the deploymenttool to maintain the rotational orientation of the implant while theactuator shaft is rotated. The anti-torque structures can comprise oneor more inwardly extending holes or indentations on the rear wedgedblock member. However, the anti-torque structures can also comprise oneor more outwardly extending structures.

According to yet other embodiments, the fusion cage 60 can be configuredto include one or more additional apertures to facilitateosseointegration of the fusion cage 60 within the intervertebral space.The fusion cage 60 may contain one or more bioactive substances, such asantibiotics, chemotherapeutic substances, angiogenic growth factors,substances for accelerating the healing of the wound, growth hormones,antithrombogenic agents, bone growth accelerators or agents, and thelike. Indeed, various biologics can be used with the fusion cage 60 andcan be inserted into the disc space or inserted along with the fusioncage 60 The apertures can facilitate circulation and bone growththroughout the intervertebral space and through the implant. In suchimplementations, the apertures can thereby allow bone growth through theimplant and integration of the implant with the surrounding materials.

In one embodiment, the fusion cage 60 comprises an expandable cageconfigured to move a first surface vertically from a second surface byrotation of at least one screw that rotates without moving transverselywith respect to either said first or second surface, said first plateand second plate having perimeters that overlap with each other in avertical direction and that move along a parallel line upon rotation ofthe screw.

In one embodiment, the fusion cage 60 is stackable by any means known tothose skilled in the art. For example, each upper plate 200 may befitted with one or more notches on the lateral edges configured to fitwith one or more protrusions on each lower plate 210.

Surprisingly, while conventional practice assumed that the amount ofmaterial that would be required, let alone desired, to fill a prepareddisc space with bone paste (or BMP, etc.) would be roughly equivalent tothe amount of material removed from such space prior to inserting acage, a present inventor discovered that far more bone graft materialcan be—and should preferably be—inserted into such space to achievedesired fusion results. The reasons why this basic under appreciationfor the volume of bone graft necessary to achieve optimal fusion resultsvary, but the clinical evidence arrived at via practice of the presentinvention compellingly demonstrates that more than doubling of theamount of bone graft material (and in some cases increasing the amountby 200%, 300% or 400% or more) than traditionally thought necessary orsufficient, is extremely beneficial to achieving desired results fromfusion procedures.

The ramifications of this simple yet dramatic discovery (documented inpart below) is part of the overall inventive aspect of the presentinvention, as it has been—to date—simply missed entirely by thepracticing spine surgeons in the field. The prospect of reduced returnsurgeries, the reduction in costs, time, and physical suffering bypatients, as well as the volume of legal complaints against surgeons andhospitals due to failed fusion results, is believed to be significant,as the evidence provided via use of the present invention indicates avast reduction in the overall costs involved in both economic resources,as well as emotional capital, upon acceptance and wide-spread use of thepresent invention. Insurance costs should thus decrease as the presentinvention is adopted by the industry. While the costs of infusingincreased amount of bone graft materials into the space of a patient'sdisc may at first appear to increase the costs of an individualoperation, the benefits achieved thereby will be considerable, includingthe reduction of repeat surgeries to fix non-fused spines. Thus,regardless of the actual tools and devices employed to achieve the endresult of attaining up to 100% more bone graft material being utilizedin fusion operations, (as well as other surgeries where previouslyunder-appreciated bone graft material delivery volumes have occurred)one important aspect of the present invention is directed to theappreciation of a previously unrecognized problem and the solutionthereto, which forms part of the inventive aspects of the presentinvention described and claimed herein.

In one embodiment, at least twice the amount of disk material removedfrom a surgical site is replaced with bone graft material. In apreferred embodiment, at least three times the amount of disk materialremoved from a surgical site is replaced with bone graft material. In amost preferred embodiment, at least three and a half times the amount ofdisk material removed from a surgical site is replaced with bone graftmaterial.

Experimental Results

The following experimental results are with respect to an apparatus andmethod for near-simultaneous and integrated delivery of bone graftmaterial in a patient's spine. These results are sample results and arenot intended to limit the invention.

Materials and Methods

During the time period from July 2010 through December 2012, a set ofpatients undergoing minimally invasive (MIS) transverse lumbar interbodyfusion (T-LIF) at the L4-5 and/or L5-S1 levels were studied for diskmaterial removed and BG delivered at each disk space during the surgicalprocedure. The diagnosis was spondylosis or spondylolisthesis in allpatients. A total of 63 patients with an average age of 56 years werestudied. There were 29 male and 34 female patients. Ninety-one diskspaces were analyzed. A single surgeon with the same surgical teamperformed all surgeries. The operations were carried out through a 22 mmcannula with microscopic control. The midline structures and spinousprocess attachments were left undisturbed. The disk space was debridedexhaustively using non-motorized, hand tools to bleeding subchondralbone. The debrided disk material was measured in a volumetric syringe.Bone Graft (BG) material consisting of silicated tricalcium phosphategranules and hyaluronic acid powder were mixed in a 1:1 ratio and localbone graft and bone marrow aspirate concentrate were added together toform a slurry. The slurry was measured volumetrically. Disk spacemobilization and distraction was carried out with serial impaction ofdistractor tools until appropriate disk height was achieved. Distractionranged from 8 mm to 14 mm, with the 10 mm or 12 mm height being mostcommonly observed.

The BG delivery tool of this disclosure was used to apply the BG slurryto the disk space. The embodiment had a rectangular cross section withthe same footprint as a small fusion cage (8 mm×12 mm). The tapered tipwas placed into the debrided disk space under microscopic control toallow for direct visualization, followed by the application of a snap-onfunnel for loading the BG. The BG slurry was then placed in the funneland the slurry was pushed into the disk space with the plunger. Thebiportal design of the delivery tool directed the slurry into thelateral areas of the prepared disk space, leaving a natural void for thefusion cage once the tool was removed. Once the disk space was filledentirely, the site of insertion was inspected for any BG material, whichmight have escaped the confines of the disk space. This material wasexcluded in the final measurement to ensure an accurate calculation ofBG delivery. Removal of the delivery tool provided an unobscured pathfor the fusion cage to be applied.

A polyether ether ketone, hollow interbody fusion cage of theappropriate size was then placed into the disk space. A minimallyinvasive, bilateral pedicle screw/rod system was applied prior to woundclosure. Average blood loss for the procedures was 127 ml+/−75 ml.

A two-tailed student's t-test was used to determine if any significantdifference existed between the volumes of disk material removed at L4-5versus L5-S1. The null hypothesis was that no significant differenceexisted between samples. Significance was set at p<0.05. The two-tailedt test was also used to determine whether a significant differenceexisted between volumes of BG delivery and disk material removed. Theformula [(BG delivered+graft volume of the fusion cage)/disk materialremoved] was used to generate the ratio of BG delivery versus diskmaterial removed.

In order to compare the volume of disk material removed during a T-LIFprocedure with a complete, surgical diskectomy, the volume of diskmaterial removed during L5-S1 anterior lumbar diskectomy was measuredvolumetrically. The L5-S1 disk was harvested and measured for patientsundergoing either anterior fusion or total disk replacement. Thematerial removed consisted of anterior and posterior annulus as well ascomplete nuclectomy, and represented more tissue (in terms of theannuli) than would be typically removed in a T-LIF procedure. There were29 anterior L5-S1 diskectomy patients. The age range, genderdistribution and diagnosis were the same as the T-LIF patients.

All study patients were followed up with anterior/posterior radiographsand a physical examination at 4 weeks, 12 weeks, 26 weeks and 52 weekspost surgery. A visual analog scale (VAS) for pain was obtained at eachvisit and an Oswestry Disability Index (ODI) was completedpreoperatively and at 26 weeks postoperatively.

Results

There were 58 L4-5 disk spaces and 33 L5-S1 disk spaces evaluated. Theaverage volumes of disk material harvested from L4-5 and L5-S1 were 4.1ml+/−2.2 ml and 2.8 ml+/−1.9 ml, respectively. The p-value for thestudent's two-tailed t-test was equal to 0.01, revealing a significantdifference in terms of disk material removed between L4-5 and L5-S1. Therange of volume was less than 1 ml to 14.5 ml. The comparison betweendisk material removed and BG material inserted at L4-5 or at L5-S1demonstrated a significant difference (p<<0.001).

BG volume applied to L4-5 was 9.8 ml+/−3.3 ml. At L5-S1 it was 8.6ml+/−3.2 ml. The p-value for the student's two-tailed t-test was equalto 0.07, trending to a significant difference in bone graft appliedbetween L4-5 and L5-S1. The combined average was 9.2 ml+/−3.0 ml. Thevolume of BG applied ranged from 4.5 ml to 19 ml. The formula of [(BGdelivered+graft volume of the fusion cage)/disk material removed]generated a surprising result: The amount of disk material removedcompared to the amount of BG placed in the disk space was not a 1:1ratio, as would have been empirically expected. At L4-5 the ratio was3.4+/−2.2 and at L5-S1 it was 4.7+/−2.7, as shown in FIGS. 34A-B,respectively. This was statistically significant with a p-value of 0.02.With respect to the entire study, the ratio of BG inserted relative todisk material removed revealed that on average 3.7+/−2.3 times as muchBG was inserted into the disk space as disk material removed. Thisfinding was even more dramatic with collapsed disk spaces where 1 ml ofdisk material harvest led to an average of 6.6 ml+/−0.9 ml of BGdelivery, as shown in FIGS. 35A-B. The volume of BG delivery wasasymptotically related to the volume of disk material removed with 12.3ml of disk material being delivered to a disk where 8.0 ml of disk wasremoved, as shown in FIGS. 35A-B.

The average volume of disk material removed during a T-LIF diskectomy atL5-S1 was 3.2 ml and the average volume of disk material from theanterior L5-S1 diskectomy was 8.1 ml. Dividing the average T-LIF volumeby the average anterior diskectomy (including annuli) volume revealedthat on average 34% of the disk material was removed at the time ofT-LIF at the L5-S1 disk space.

Because of the tapered tip of the BG delivery tool, it was possible toenter the most collapsed disk space without endplate injury. Thedelivery device did not jam with the application of the BG slurry. Theremovable funnel allowed direct visualization of the tool under themicroscope without obscuring its tip during insertion. Because thedelivery device applied BG out of its side portals, it provided anatural void for fusion cage insertion, and no cage jamming resultedduring impaction. BG delivery using the described tool took a fractionof the time (less than 2 minutes) usually devoted to depositing BG tothe disk space. There were no complications associated with the use ofthe BG delivery tool.

The average preoperative ODI measured 29+/−9 and the postoperative valuewas 21+/−8. A significant difference was not detected with p=0.06. TheVAS similarly improved with pre-operative score measuring 7.5+/−1.5 andpostoperative score 4.0+/−2.5. The postoperative VAS was statisticallysignificant relative to the corresponding preoperative value withp<0.05.

Pseudoarthrosis developed in 7 disks in 4 patients (7.6%). The patientswith 2-level pseudoarthrosis had a diagnosis of hypothyroidism. Thisdiagnosis was also present in one of the single level pseudoarthosispatients. The remaining pseudoarthrosis patients did not havediscernable risk factors (diabetes, tobacco consumption or obesity).

Discussion

There is substantial variation in fusion rates after T-LIF surgery withpseudoarthrosis rates varying from 23.1% to 2.9%. The reasons for therange of successful arthrodesis vary from surgical technique, includingBG preparation and application, to the way in which a pseudoarthrosis isdiagnosed—direct surgical exploration or by radiographic means. Reasonwould dictate that the volume of BG delivered to a prepared disk spacewould contribute positively to successful arthrodesis with inadequategrafting leading to pseudoarthrosis. Using hand tools and the goal ofdisk space debridement, a conservative estimate of 34% of disk removalwas observed in this study at the L5-S1 level. This substantialdifference represents the different goals of the procedures and providesa baseline for general disk space debridement for T-LIF procedures.

The statistically significant difference between the amount of diskmaterial removed from L4-5 versus L5-S1 correlates with the commonlyobserved radiographic finding of disk height at L4-5 being greater thanthat of L5-S1. Likewise, BG delivery to L4-5 was greater relative to theL5-S1 disk space. Although direct volume of BG insertion was greater inL4-5 relative to L5-S1, the ratio (BG delivered/disk material removed)was higher at L5-S1 (4.7+/−2.7) than at L4-5 (3.4+/−2.2). This was astatistically significant difference (p<0.02) and corresponds with themore collapsed disk spaces demonstrating a higher percentage of BGdelivery (see FIGS. 34A-B).

On average, 3.7 times as much bone graft was applied to the debrideddisk space relative to disk material removed. This is explained by thefact that the disk space was collapsed at the time of diskectomy, andthen distracted and mobilized during the preparation process to adistracted height. This suggests that relying on an empiric 1:1 ratio ofdisk removal to BG insertion grossly under-fills the disk space andwould be an important contributor to pseudoarthrosis. This is anespecially important consideration in the most collapsed disk spacessince distraction to appropriate height in a non-collapsed disk reducesthe ratio to 8:12.3 (see FIG. 35A) or a 1:1.4 ratio.

The BG slurry used in this study consisted of a mixture of granularmaterial and liquid. This combination of materials does not behave as atypical, Newtonian (non-compressible) fluid. A non-Newtonian fluid willexude its fluid component as it is compressed, and the residual granularBG material occludes a conventional, cylindrical BG delivery device.

The BG delivery tool in this study revealed a number of advantages inthat it allowed for BG application in collapsed disc spaces due to itswedged tip, a process which is not possible with round-ended injectioncannulas. The increased cross sectional footprint relative to a roundcannula allowed considerably less friction of non-Newtonian fluidmaterial through the cannula, resulting in an increase in the BG flowdynamics, and eliminating jamming due to BG impaction. It is estimatedthat changing the cross-sectional area from 8 mm×8 mm to 8 mm×12 mmimproves the flow dynamics of a non-Newtonian fluid by 40%. The twosites for BG extrusion at the sides of the cannula tip double the exitzone surface area, further decreasing the resistance to flow of thegranular mixture. The removable funnel allowed direct visualization ofthe cannula as it was applied to the disk space without being obscuredby the funnel. The biportal expression of the BG material allowed graftinoculation of all prepared areas of the disk space and left a void forthe fusion cage. The applied BG delivery tool allowed refilling of thecannula without having to remove the device, resulting in decreasedpotential trauma to the adjacent nerve tissue.

The fusion rate in this study was 92.4% with three of thepseudoarthrosis patients having a diagnosis of hypothyroidism. This maybe related to abnormalities in bone metabolism associated in patientswith endocrinopathy. The other pseudoarthrosis patients did not haveapparent risk factors. Postoperative pain scores and functionalimprovement correlated with progression to arthrodesis.

In summary, preparation of the disk spaces at L4-S1 can deliver 34% ofthe disk volume during debridement. BG delivery was on average 3.7 timesthe volume of disk removal with a relatively higher ratio of BG beingdelivered to the more collapsed disk spaces. A novel BG delivery devicecan be used to dispense a volume of BG to the disk space that is capableof filling the entire debrided area in an efficient and safe fashion.This should allow for maximization of arthrodesis potential, increasepatient safety, and decrease operative time.

FIG. 75 is a perspective view of a bone graft delivery device 502according to the prior art. The bone graft delivery device 502 comprisesa first end 504 and a second end 516, with an elongate shaft 508provided therebetween. The first end 504 comprises a funnel 512 forreceiving material and providing the material to the elongate shaft 508.The second end 516 comprises an outlet aperture 510 through which bonegraft material may exit the device and be provided to a disc space (forexample). Bone graft delivery devices of the present disclosure,including the device shown in FIG. 75, are contemplated as comprisingindicia 511, including indicia that is operable to indicate an extent ofinsertion of the second end 516 of the device into a surgical work site.

FIG. 76 is a cross-sectional view of a bone graft delivery device 512provided in combination with a surgical work site 522. Specifically, abone graft delivery device 512 is shown as providing a bone graftmaterial 524 to an intervertebral space 522 within a human spine 520.The tool 502 is generally inserted into a patient from a lateral accesssite, and a second end of the delivery device 512 is provided within theintervertebral space to which bone graft material 524 is to be provided.FIG. 76 depicts a conventional end-dispensing cannula that ejects andinjects bone graft material directly into the intended path of a fusioncage. The device and method of FIG. 76 does not distribute bone graftdelivery material into the periphery of the prepared disc space andgenerally fails to achieve appropriate distribution of bone graftdelivery material.

FIG. 77 is a plan view of a bone graft delivery device 530 according toone embodiment of the present disclosure. As shown, the device 530comprises an elongate shaft 532 and a handle 534 extending substantiallyperpendicular thereto. The handle 534 comprises a user-interface meansthat extends away from the elongate shaft portion 532 of the device. Thehandle 534 is connected to the device proximal to a first end 538 of thedevice 530. In various embodiments, the connection 536 between thehandle 534 and the elongate shaft 532 comprises a permanent connection,such as a welded connection between the two components. In alternativeembodiments, it is contemplated that the handle 534 is selectivelydetachable from the elongate shaft portion 532 of the device 530. Forexample, in some embodiments, it is contemplated that the handle 534comprises a threaded connection for selectively attaching the handle 534to the elongate shaft 532 of the tool 530. As further shown in FIG. 77,the device comprises a removable funnel member 540. The removable funnel540 is operable to connect to the first end 538 of the device and iscapable of facilitating the insertion of bone graft material to apatient via the elongate shaft 532 of the tool 530. The funnel 540 isoperable to insert bone graft material into the elongate and generallythin shaft 532 by providing an expanded opening for a user to feed bonegraft material into. The funnel 540 is provided as a removable devicesuch that a user may remove the funnel 540 after bone graft material hasbeen inserted and such that the funnel 540 does not obstruct a user'sview of a surgical work site after the funnel is no longer needed.

FIG. 78 is a top plan view of a surgical work site and a bone graftdelivery device 530 according to one embodiment of the presentdisclosure. As shown, the bone graft delivery device 530 comprises anextending handle 534 and the device 530 is provided in a surgicalworksite 539. The surgical tool preferably comprises an ovoid internalcross-section 542 with an enhanced area. For illustrative purposes, aconventional tool's cross-section 540 is shown. Conventional deviceswith cross-sections represented by section 540 of FIG. 78 generallycomprise an area of less than 50 mm², and specifically of approximately38 mm². In contrast, tools and devices of the present disclosurecomprise an internal area of at least approximately 70 mm² andpreferably of at least 78 mm².

FIG. 79 is a detailed perspective view of a distal end of a bone graftdelivery device 530. As shown, the device 530 comprises an elongateshaft 532 that terminates with a contoured distal end 544. As shown, thedistal end of the device 544 comprises a closed end, and at least oneaperture 546 is provided along a length of the shaft 532 for allowingegress of bone graft material to a surgical work site. The distal end544 of the tool 530 preferably comprises a rounded or curved end tofacilitate insertion into a workspace, including collapsed or restricteddisc spaces. It is contemplated that the distal end 544 of the tool 530is to be provided within a work site after the work site has beenprepared and cleaned by additional components. However, it has beenobserved that even after clearing of a disc space (for example) byconventional tools and methods, some obstructions may still be present.It has been found that a rounded, curved, or pointed distal end 544 asshown in FIG. 79 eases insertion and prevents damage or injury to apatient.

Whereas conventional devices comprise an open distal end (see FIG. 75,for example), the closed and rounded distal end 544 of the presentinvention is further provided with at least one and preferably two ormore apertures 546 on a lateral portion of the shaft 532 to facilitateegress of bone graft material from the device and to avoid injection ofbone graft material directly into an intended path of insertion for afusion cage.

FIG. 80 is an elevation view of a surgical access site, including apatient's spine 550 and a bone graft delivery device provided andextending into an intervertebral disc space 545. The elongate shaft 532extends into a disc space 545 wherein the distal end of the device isprovided between vertebrae. The device is preferably inserted far enoughinto the disc space that the aperture(s) 546 provided on lateral sidesof the shaft 532 are also positioned within the disc space. Accordingly,after debridement of the disc space 545 through appropriate methods, newbone graft material may be inserted into the disc space 545 by providingthe bone graft material through the elongate shaft 532 and ejecting thebone graft material through the apertures 546 into the disc space 545.Although not shown in FIG. 80, a fusion cage may be in the disc space545 prior to and/or subsequent to injection of bone graft material.

FIG. 81 is a top plan view of a surgical site and an injection of bonegraft material 552 according in accordance with methods and systems ofone embodiment of the present disclosure. As shown, an elongate shaft532 of a bone graft delivery device is provided and wherein a rounded orcurved distal end 544 of the device extends into a surgical site whichis shown as an intervertebral disc space of a patient's spine 550 inFIG. 81. As shown in FIG. 81, bone graft material 552 is provided to anintervertebral space by ejecting the material from first and secondapertures 546 provided in sidewalls of the elongate shaft 532 of thebone graft delivery tool. The tool and method of FIG. 81 provides formultiple ejection ports for delivery and enhanced distribution of bonegraft material into a surgical site. The elongate shaft 532 of thedevice and associated apertures 546 are operable to provide a greateramount of bone graft material to a work space as compared to existingdevices and methods by providing enhanced distribution, for example. Asopposed to conventional methods and devices, bone graft delivery devicesof the present disclosure avoid injection of bone graft materialdirectly into the path or intended path of a cage (see FIG. 76). Devicesof the present disclosure provide for a sufficient amount of bone graftmaterial is provided to a workspace and wherein a receiving area isprovided that is operable to receive a fusion cage.

FIG. 82 is a top view of the surgical workspace according to FIG. 81,and wherein the bone graft delivery tool has been removed afterinsertion or injection of the bone graft material 552. As shown in FIG.82, removal of the bone graft delivery tool provides for an unobstructedpath 554 and void space for subsequent insertion of a fusion cage (notshown in FIG. 82). Annulotomy is performed as a step in the method(s) ofintradiscal decompression and the resolution of disco radicular conflictas contemplated by various embodiments of the present disclosure. Thebone graft material 552 is provided before, during, and/or afterinsertion of the appropriate fusion cage.

FIGS. 83-84 depict methods and devices for preparing a bone graftmaterial 570 according to one embodiment of the present disclosure.Specifically, bone graft material 570 is partially prepared by providingthe material 570 within a graduated syringe 560 and the bone graftmaterial is compressed or compacted to form a desired and measuredamount of bone graft material. The bone graft material 570 is thereafterprepared for insertion into a surgical workspace, including (but notlimited to) an area of disc debridement in a surgical setting.

Methods and systems of the present disclosure provide for increasedamounts of bone graft delivery material being delivered to a disc space,and therefore improve and expedite post-surgical recovery processes. Invarious embodiments, it is contemplated that between approximately 2.5mL and 5.7 mL of disc material is removed from a surgical site, andbetween approximately 6.2 mL and 12.2 mL of bone graft delivery materialis provided to the same space. Complete filling of a prepared disc spaceand subsequent fusion and incorporation of bone graft delivery materialis provided. Enhanced bone graft delivery is accomplished throughvarious methods and devices of the present disclosure including, forexample, lateral apertures or ports provided in a bone graft deliverydevice to inject or insert bone graft material without obstruction apath of a cage, and through enhanced cage systems wherein an interiorvolume of disc space can be increased. In a prepared, distracted discspace, a volume of a generally cylindrical space is increased andimproved, increased amounts of bone graft delivery material is provided.

While various embodiment of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter.

What is claimed is:
 1. A bone graft delivery kit comprising: a hollow tube having a proximal end and a distal end, the hollow tube configured to convey graft material to a graft receiving area in a patient, the hollow tube connected to an implant; and a plunger to facilitate moving the graft material through the hollow tube.
 2. The kit of claim 1, wherein the implant is a hollow cage
 3. The kit of claim 1, wherein the implant includes openings configured for the passage of graft material therethrough.
 4. The kit of claim 1, further comprising a detachable funnel adapted to connect to the proximal end of the hollow tube, wherein the detachable funnel facilitates insertion of bone graft into the hollow tube.
 5. The kit of claim 1, further comprising an installer/impactor configured to engage the proximal end of the hollow tube.
 6. The kit of claim 1, further comprising removal pliers that are configured to engage the hollow tube and separate it from the implant.
 7. The kit of claim 1, wherein the at least one hollow tube is preloaded with one of bone graft and bone morphogenic protein.
 8. A bone graft delivery kit comprising: at least one hollow tube constructed to receive bone graft and having a proximal end and a distal end; a funnel configured (i) to be disposed at the proximal end of the at least one hollow tube, (ii) to receive bone graft material and (iii) to deliver bone graft material into the at least one hollow tube; and at least one plunger adapted for inserting into the proximal end of the at least one hollow tube.
 9. The kit of claim 8, further comprising an implant that is configured to engage the distal end of the hollow tube.
 10. The kit of claim 9, wherein the implant is a hollow cage.
 11. The kit of claim 9, further comprising removal pliers that are configured to engage the at least one hollow tube and separate it from the implant.
 13. The kit of claim 9, wherein the implant is an intervertebral implant.
 14. The kit of claim 8, wherein the at least one hollow tube is preloaded with one of bone graft and bone morphogenic protein.
 15. A bone graft insertion kit comprising: at least one one-piece hollow tube having a length, a proximal end, a distal end, and a rectangular interior cross-section extending from the proximal end to the distal end; at least one one-piece plunger adapted for insertion within the at least one one-piece hollow tube at the hollow tube proximal end, the at least one one-piece plunger having (i) a distal end exterior surface of rectangular cross-section forming a substantially congruent fit with the hollow tube rectangular interior cross-section, (ii) a distal tip contoured to conform to the hollow tube distal end and (iii) an axial length at least sufficient wherein at a least a portion of the plunger distal end is positioned adjacent to the at least one lateral opening when the at least one one-piece plunger is fully inserted into the at least one one-piece hollow tube; and wherein the at least one one-piece hollow tube and the at least one one-piece plunger are configured to deliver bone graft material to a graft receiving area.
 16. The kit of claim 15, further comprising an implant that is configured to engage the distal end of the hollow tube.
 17. The kit according to claim 16, wherein the implant is a hollow cage.
 18. The kit of claim 16, further comprising removal pliers that are configured to engage the hollow tube and separate it from the implant.
 19. The kit of claim 15, wherein the at least one hollow tube is preloaded with one of bone graft and bone morphogenic protein.
 20. The kit according to claim 15, further comprising a funnel configured for attaching to the hollow tube proximal end and receiving bone graft. 